Sjögren's SyndromePhase 2NCT01316770

Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

A Phase 2 study testing Dexamethasone Parotid Irrigation in people with Sjögren's Syndrome and Xerostomia, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Background: Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Sjögren's Syndrome, Xerostomia
What is being tested?: Dexamethasone Parotid Irrigation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 May 2011to 17 Apr 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female gender and age 18 and greater.
Diagnosed with primary SS in Protocol 84-D-0056.
Stimulated salivary flow of at least 0.01 mL/min from each parotid gland, using the standard operating procedure (SOP) for the National Institute of Dental and Craniofacial Research (NIDCR) Molecular Physiology and Therapeutics Branch (MPTB) Sjögren's Syndrome Clinic
Minor salivary gland (MSG) biopsy with a focus score of greater than or equal to 1 obtained 0 to 7 years prior to study enrollment. Biopsies from outside of the National Institutes of Health (NIH) must be reviewed by the NIH Pathology Department. An MSG biopsy will be required for the following situations:
The last biopsy was obtained before the use of rituximab.
The last biopsy was obtained before the use of immunosuppressants, biologics, or disease-modifying antirheumatic drugs for more than 3 months.

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The last biopsy was obtained before the use of systemic corticosteroids (for more than 2 weeks or for shorter periods at doses of more than 0.5 mg/kg) or local parotid corticosteroids. The use of topical or intra-articular/periarticular corticosteroids will not require a repeat biopsy.
For women of childbearing potential, use of, or willingness to use, an effective method of birth control during the study. Effective methods include abstinence, history of hysterectomy, tubal ligation, intrauterine device, licensed hormonal methods, condoms, diaphragm, and cervical cap.
Ability to provide written informed consent prior to entry in the study.

Who cannot join

History of lymphoma.
History of mycosis, aspergillosis, or other deep fungal infection of the parotid gland.
History of salivary gland malignancy (primary or metastatic to the salivary gland).
History of secondary Sjögren's syndrome.
Parotid infection that does not resolve at least 4 weeks before the start of the Screening Period.
Any active viral infection that does not resolve by the start of the Screening Period.

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Pregnancy or lactation.
Use of biologics within 3 months of the start of the Screening Period.
Any experimental therapy within 3 months before the start of the Screening Period.
Use of immunosuppressants such as methotrexate, leflunomide, azathioprine, cyclophosphamide, systemic cyclosporine, or systemic corticosteroids within 3 months prior to the start of the Screening Period.
Use of inhaled corticosteroids within 3 months prior to the start of the Screening Period.
Use of antimalarials and regular use of NSAIDs unless the dose has been stable (or decreased) for at least 2 months.
Inability to discontinue the use of saliva stimulants such as pilocarpine and cevimeline for 24 hours before each study visit.
Parotid intraductal irrigation or instillation with steroids within the past year.
Use of rituximab within 6 months prior to the start of the Screening Period.
Allergy to steroids or technetium, or any components of the formulations.
Current use of warfarin or heparin.
History of bleeding disorder.
Both severe atrophy and fibrosis of the MSG noted on the pathology report of the MSG biopsy.
Inability to comply with protocol procedures and the number of required visits.
Inability to cannulate one or both parotid glands.
Parotid fill volume less than 0.5 mL in one or both parotid glands.
Significant concurrent medical condition or other circumstances that, in the opinion of the principal investigator, could affect the subject's ability to tolerate or complete the study.
Unable to understand written English for completion of study questionnaires.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

Background:

Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works.

Objectives:

To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome.

Eligibility:

Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.

Design:

Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.
At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.
Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.
Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.
Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.

Read the detailed description

BACKGROUND:

Salivary gland dysfunction is one of the major manifestations of Sjögren's (SS). Although inflammation is thought to play an important role in the exocrinopathy, the correlation between glandular dysfunction and inflammation is limited. Systemic anti-inflammatory therapies tested to date, such as tumor necrosis factor antagonists, have not been effective treatments for SS salivary hypofunction, raising doubts about inflammation being the sole cause of salivary gland dysfunction. However, none of these trials tested whether an anti-inflammatory effect was achieved in glandular tissues.

Studies by Izumi et al found that a limited course of low-dose topical corticosteroid applied to the parotid glands resulted in sustained improvement in saliva production. Unfortunately, these studies did not examine the mechanistic effects of corticosteroids on the major salivary glands. A plausible assumption is that corticosteroids improved salivary gland function by reducing inflammation, although other or associated mechanisms, such as an improved transcellular ion transport in epithelial cells cannot be ruled out. This study aims to study the efficacy of low-dose topical corticosteroid (dexamethasone) irrigation of the parotid gland in reducing salivary dysfunction in subjects with SS, and also to evaluate the effects of treatment on inflammation and other possible mechanistic processes.

PRIMARY OBJECTIVE:

To determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects.

SECONDARY OBJECTIVES:

To perform mechanistic studies to determine the mechanisms of action of low-dose topical corticosteroid irrigation of the parotid gland.
To assess biomarkers of inflammation and salivary gland dysfunction in SS subjects treated with low-dose topical corticosteroid irrigation of the parotid glands.
To assess localized safety of dexamethasone irrigation of the parotid gland, as compared with placebo.

STUDY POPULATION:

The study will enroll up to 20 adult females with primary SS in order to randomize and treat 16 subjects. Key enrollment criterion include a focus score of greater than or equal to 3 on minor salivary gland biopsy in the previous 5 years and measurable stimulated bilateral parotid salivary flow (greater than or equal to 0.01 mL/min per gland). Subjects will be recruited from protocol 84-D-0056, conducted at the National Institutes of Health (NIH).

DESIGN:

This will be a single-site, randomized-within-subject, double-blind, placebo-controlled, phase 2 pilot study in which all subjects receive both active drug (dexamethasone) and placebo (normal saline), thereby acting as their own controls.The study design is doubly-repeated measures; within a subject, measures are repeated in both time and treatment (i.e., one side of mouth receives dexamethasone while the other receives placebo.). After baseline assessment of salivary flow and other measurements of salivary function, subjects will be randomly assigned, in a double-blind fashion, to dexamethasone irrigation of one parotid gland and normal saline irrigation of the other parotid gland. They will undergo a total of 2 treatment sessions, 4 weeks apart (Days 0 and 28). Post-treatment assessments of salivary flow, dry mouth symptoms, and adverse events (AEs) will be performed at specified intervals.

OUTCOME MEASURES:

Primary Endpoint:

Change in salivary flow from Day 0 to Day 56.

Secondary Endpoints:

Change in focus score on parotid biopsy from Screening to Day 56.
Change in salivary flow from Day 0 to study Days 14, 28, 42, and 56.
Changes in assessments on the Patient Dry Mouth Questionnaire from Day 0 to study Days 14, 28, 42, and 56.
Changes in assessments on the Sj(SqrRoot)(Delta)gren s Disease Activity Index from Day 0 to study Days 14, 28, 42, and 56.
Changes in other assessments of salivary function from baseline to study Day 56, including technetium scan of the salivary glands.
Changes in laboratory measures of inflammation.
Frequency of AEs related to treatment; AE location (body site, right or left), will be recorded and evaluated, as applicable.

Exploratory endpoints

Changes in mechanistic endpoints from baseline to study Days 14, 28, 42, and 56.

Conditions: Sjögren's Syndrome, Xerostomia
Being tested: Dexamethasone Parotid Irrigation, Placebo Parotid Irrigation
Keywords: Xerostomia, Sjögren's Syndrome, Interventional Study, Sjogren's Syndrome, Dry Mouth
Medical subject headings: Sjogren's Syndrome, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexamethasone Parotid IrrigationDrug
Also called Placebo Parotid Irrigation
Irrigation of the parotid gland from one side of the mouth with dexamethasone.
Placebo Parotid IrrigationDrug
Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.

Study groups in NCT01316770
Study group	Role	What they receive
Placebo Parotid Irrigation	Placebo comparator	Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency} Receives: Drug: Placebo Parotid Irrigation
Dexamethasone Parotid Irrigation	Experimental	Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency} Receives: Drug: Dexamethasone Parotid Irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.
Measured: Baseline (Study Day 0) to Study Day 56

Secondary outcomes (46)

Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.
Measured: Baseline to 14 days post-baseline
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.
Measured: Baseline to 28 days post-baseline
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.
Measured: Baseline to 42 days post-baseline
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify:
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?
The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Measured: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?
Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)
Ordinal Scale 0:least to 10:greatest level of disease activity
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)
Nominal scale values: Inactive; Low; Moderate; High
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?
Response: Yes or No
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores
Ordinal Scale 0: least to 10: greatest level of disease activity.
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:
Nominal Scale: Much better; Better; The same; Worse; Much worse
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome):
Response: Yes; No
Measured: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days.
Possible Response: Yes or No
Measured: Baseline (Study Day 0) through Study Day 56
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) through Study Day 14
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) through Study Day 28
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) through Study Day 42
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) through Study Day 56
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale
Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.
Measured: Baseline (Study Day 0) to Study Day 56
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) to Study Day 14
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) to Study Day 28
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) to Study Day 42
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale
Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Measured: Baseline (Study Day 0) to Study Day 56
Summary Statistics of MRI Scans
Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.
Measured: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit
Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).
Measured: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Summary Statistics of Technetium Scans
Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.
Measured: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit
Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.
Measured: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Summary Statistics of Focus Score
Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).
Measured: Stage II screening (within 6 wks before baseline) through 56 days post-baseline
Shift Table of Focus Scores From Stage II Screening to Study Day 56
Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.
Measured: Stage II Screening (within 6 wks before baseline) through 56 days post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201117 Apr 2017

First posted16 Mar 2011 (estimated)
Study start1 May 2011
Primary completion17 Apr 2017
Study completion17 Apr 2017

Why it stopped: Slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01316770
Sponsor's protocol ID: 110094
Other IDs: 11-D-0094
Status last verified: Nov 2018
First submitted: 15 Mar 2011
Last updated: 2 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Izumi M, Eguchi K, Nakamura H, Takagi Y, Kawabe Y, Nakamura T. Corticosteroid irrigation of parotid gland for treatment of xerostomia in patients with Sjogren's syndrome. Ann Rheum Dis. 1998 Aug;57(8):464-9. doi: 10.1136/ard.57.8.464.
PubMed 9797551
Takagi Y, Katayama I, Tashiro S, Nakamura T. Parotid irrigation and cevimeline gargle for treatment of xerostomia in Sjogren's syndrome. J Rheumatol. 2008 Nov;35(11):2289-91. doi: 10.3899/jrheum.080370. No abstract available.
PubMed 19004065
Manor W. A clinical learning experience in discharge planning. Nurse Educ. 1991 Nov-Dec;16(6):35. No abstract available.
PubMed 1754137

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Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Sjögren's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
ClinicalTrials.gov ID: NCT01316770
Acronym / sponsor ID: 110094
Conditions: Sjögren's Syndrome, Xerostomia
Keywords: Xerostomia, Sjögren's Syndrome, Interventional Study, Sjogren's Syndrome, Dry Mouth
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 14 participants (actual)
Lead sponsor: National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
Study start: 1 May 2011
Primary completion: 17 Apr 2017 (actual)
Study completion: 17 Apr 2017 (actual)
First posted: 16 Mar 2011 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

Objectives:

To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome.

Eligibility:

Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.

Design:

Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.
At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.
Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.
Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.
Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.

Detailed description

BACKGROUND:

PRIMARY OBJECTIVE:

To determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects.

SECONDARY OBJECTIVES:

To perform mechanistic studies to determine the mechanisms of action of low-dose topical corticosteroid irrigation of the parotid gland.
To assess biomarkers of inflammation and salivary gland dysfunction in SS subjects treated with low-dose topical corticosteroid irrigation of the parotid glands.
To assess localized safety of dexamethasone irrigation of the parotid gland, as compared with placebo.

STUDY POPULATION:

DESIGN:

OUTCOME MEASURES:

Primary Endpoint:

Change in salivary flow from Day 0 to Day 56.

Secondary Endpoints:

Change in focus score on parotid biopsy from Screening to Day 56.
Change in salivary flow from Day 0 to study Days 14, 28, 42, and 56.
Changes in assessments on the Patient Dry Mouth Questionnaire from Day 0 to study Days 14, 28, 42, and 56.
Changes in assessments on the Sj(SqrRoot)(Delta)gren s Disease Activity Index from Day 0 to study Days 14, 28, 42, and 56.
Changes in other assessments of salivary function from baseline to study Day 56, including technetium scan of the salivary glands.
Changes in laboratory measures of inflammation.
Frequency of AEs related to treatment; AE location (body site, right or left), will be recorded and evaluated, as applicable.

Exploratory endpoints

Changes in mechanistic endpoints from baseline to study Days 14, 28, 42, and 56.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Parotid Irrigation	Placebo comparator	Drug: Placebo Parotid IrrigationWithin-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency}
Dexamethasone Parotid Irrigation	Experimental	Drug: Dexamethasone Parotid IrrigationWithin-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency}

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Female gender and age 18 and greater.
Diagnosed with primary SS in Protocol 84-D-0056.
Stimulated salivary flow of at least 0.01 mL/min from each parotid gland, using the standard operating procedure (SOP) for the National Institute of Dental and Craniofacial Research (NIDCR) Molecular Physiology and Therapeutics Branch (MPTB) Sjögren's Syndrome Clinic
Minor salivary gland (MSG) biopsy with a focus score of greater than or equal to 1 obtained 0 to 7 years prior to study enrollment. Biopsies from outside of the National Institutes of Health (NIH) must be reviewed by the NIH Pathology Department. An MSG biopsy will be required for the following situations:
The last biopsy was obtained before the use of rituximab.

Key exclusion criteria (24 listed)

History of lymphoma.
History of mycosis, aspergillosis, or other deep fungal infection of the parotid gland.
History of salivary gland malignancy (primary or metastatic to the salivary gland).
History of secondary Sjögren's syndrome.
Parotid infection that does not resolve at least 4 weeks before the start of the Screening Period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexamethasone Parotid IrrigationAlso: Placebo Parotid IrrigationIrrigation of the parotid gland from one side of the mouth with dexamethasone.	Drug	Dexamethasone Parotid Irrigation
Placebo Parotid IrrigationIrrigation of the parotid gland on the opposite side of the mouth with placebo saline.	Drug	Placebo Parotid Irrigation

Primary outcome

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
Time frame: Baseline (Study Day 0) to Study Day 56
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.

46 secondary outcomes

Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.
Time frame: Baseline to 14 days post-baseline
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.
Time frame: Baseline to 28 days post-baseline
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.
Time frame: Baseline to 42 days post-baseline
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify:
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?
Time frame: Baseline (Study Day 0) through Study Day 56
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome):
Time frame: Baseline (Study Day 0) through Study Day 56
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days.
Time frame: Baseline (Study Day 0) through Study Day 56
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores
Time frame: Baseline (Study Day 0) through Study Day 14
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores
Time frame: Baseline (Study Day 0) through Study Day 28
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores
Time frame: Baseline (Study Day 0) through Study Day 42
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores
Time frame: Baseline (Study Day 0) through Study Day 56
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale
Time frame: Baseline (Study Day 0) to Study Day 56
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale
Time frame: Baseline (Study Day 0) to Study Day 14
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale
Time frame: Baseline (Study Day 0) to Study Day 28
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale
Time frame: Baseline (Study Day 0) to Study Day 42
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale
Time frame: Baseline (Study Day 0) to Study Day 56

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexamethasone Irrigation of Parotid Gland	9	9
Placebo Irrigation of Parotid Gland	9	9

Primary outcome: Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.

Time frame: Baseline (Study Day 0) to Study Day 56. Mean (Standard Error). Unit: g/min

Measure	Dexamethasone Irrigation of Parotid Gland n = 9	Placebo Irrigation of Parotid Gland n = 9
Value	-0.01120 (0.049063)	-0.05204 (0.032029)

Dexamethasone Irrigation of Parotid Gland vs Placebo Irrigation of Parotid Gland: p = 0.236, one-sided Paired t-test

Population analysed: Primary Efficacy Population (PEP): all enrolled participants who receive all parotid irrigations on study Days 0 and 28, have the same treatment applied to the same parotid (regardless of random assignment) at both visits, and have values for the primary endpoint (i.e., change in salivary flow from Day 0 to Day 56).

46 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexamethasone Irrigation	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Placebo Irrigation	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Side of Mouth Not Applicable	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9797551Izumi M, Eguchi K, Nakamura H, Takagi Y, Kawabe Y, Nakamura T. Corticosteroid irrigation of parotid gland for treatment of xerostomia in patients with Sjogren's syndrome. Ann Rheum Dis. 1998 Aug;57(8):464-9. doi: 10.1136/ard.57.8.464.
Background: PubMed 19004065Takagi Y, Katayama I, Tashiro S, Nakamura T. Parotid irrigation and cevimeline gargle for treatment of xerostomia in Sjogren's syndrome. J Rheumatol. 2008 Nov;35(11):2289-91. doi: 10.3899/jrheum.080370. No abstract available.
Background: PubMed 1754137Manor W. A clinical learning experience in discharge planning. Nurse Educ. 1991 Nov-Dec;16(6):35. No abstract available.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ilias G Alevizos, D.M.D. principal investigator

National Institute of Dental and Craniofacial Research (NIDCR)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. (time frame: Baseline (Study Day 0) to Study Day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316770, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.