XerostomiaPhase 1/2NCT01369589
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
A Phase 1/2 study testing P-552 in people with Xerostomia and Sjogren's Syndrome, run by Parion Sciences at 1 site in United States.
Trial summary
The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Sjogren's Syndrome
- What is being tested?
- P-552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged 18 years or older, and who are capable of providing their written informed consent to participate in the study.
- Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom) during study participation and for at least 30 days after the completion of dosing.
- Non-pregnant female subjects must be either not sexually active, postmenopausal, or surgically sterilized; or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before receiving the first dose of study drug during study participation and at least 30 days after the completion of dosing.
- Are in good health, as determined by a medical history, a physical examination, a detailed oral examination, and results of clinical chemistry, hematology and urinalysis.
- Has minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [i.e., 0.05 grams] per 5 minutes) at the screening visit.
- Have a diagnosis of primary Sjogren's syndrome consistent with the revised version of the European criteria proposed by the American-European Consensus Group European Cooperative Community Classification Criteria for Sjogren's Syndrome.
Who cannot join
- Regularly uses antihistamines that have been started or the dose adjusted within the last 30 days.
- Has started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before Screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or is unable to maintain stable dosing throughout the study.
- Is unable to withhold the use of systemic cholinergic secretagogues and oral comfort agents (e.g., OraMoist, MouthKote, Biotene products, etc.) on the morning of each study visit and until 2 hours after dosing at study visits; and is unable to take the last nighttime dose at a standard time throughout the study.
- Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
- Shows evidence of a significant active or ongoing oral infection or other oral conditions (e.g., lichen planus) that, in the opinion of the investigator, might affect the safety of the subject or might exacerbate during study participation.
- Has acutely infected salivary glands (with or without pain) or suspected closure of the salivary glands.
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- Has received an investigational drug within the past 30 days.
- Has a history of allergy to any medicine chemically related to the study drug (e.g., amiloride, Moduretic, Midamor, triamterene).
- Has a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular (including hyper/hypotension and tachy/bradycardia), psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the investigator.
- Has viral hepatitis or tested positively for the hepatitis B surface antigen or hepatitis C (nonA, non-B) antibody, or a positive result for human immunodeficiency virus antibodies.
- Has a positive serum pregnancy test or is nursing (female subjects only).
- Should not participate in the study, in the opinion of the Principal or Clinical investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome
The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Changes in oral mucosal wetness will be assessed via collection of salivary output and via measurement of oral wetness using the Periotron 8000 instrument.
- Conditions
- Xerostomia, Sjogren's Syndrome
- Being tested
- P-552, Placebo
- Keywords
- Xerostomia, dry mouth, Sjogren's Syndrome
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-552Drug
Also called P-552 Oral Rinse
P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated.
PlaceboDrug
Also called Vehicle Oral Rinse, Water for Injection
Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated.
| Study group | Role | What they receive |
|---|---|---|
| P-552 on Day 1 and Placebo on Day 2 | Experimental | Randomly assigned subjects will receive a single dose of P-552 on Day 1 followed by a single dose of Placebo on Day 2 Receives: Drug: P-552; Drug: Placebo |
| Placebo on Day 1 and P-552 on Day 2 | Experimental | Randomly assigned subjects will receive a single dose of Placebo on Day 1 followed by a single dose of P-52 on Day 2 Receives: Drug: P-552; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary volume
Measured: 60 minutes
Salivary Volume
Measured: 120 minutes
Secondary outcomes (1)
Periotron measurement
measurement of mucosal wetness
Measured: 15, 30 and 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parion Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369589
- Sponsor's protocol ID
- 552-209S
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2011
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT01369589
- Acronym / sponsor ID
- 552-209S
- Conditions
- Xerostomia, Sjogren's Syndrome
- Keywords
- Xerostomia, dry mouth, Sjogren's Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Changes in oral mucosal wetness will be assessed via collection of salivary output and via measurement of oral wetness using the Periotron 8000 instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-552 on Day 1 and Placebo on Day 2 | Experimental | Drug: P-552, Drug: PlaceboRandomly assigned subjects will receive a single dose of P-552 on Day 1 followed by a single dose of Placebo on Day 2 |
| Placebo on Day 1 and P-552 on Day 2 | Experimental | Drug: P-552, Drug: PlaceboRandomly assigned subjects will receive a single dose of Placebo on Day 1 followed by a single dose of P-52 on Day 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females, aged 18 years or older, and who are capable of providing their written informed consent to participate in the study.
- Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom) during study participation and for at least 30 days after the completion of dosing.
- Non-pregnant female subjects must be either not sexually active, postmenopausal, or surgically sterilized; or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before receiving the first dose of study drug during study participation and at least 30 days after the completion of dosing.
- Are in good health, as determined by a medical history, a physical examination, a detailed oral examination, and results of clinical chemistry, hematology and urinalysis.
- Has minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [i.e., 0.05 grams] per 5 minutes) at the screening visit.
Key exclusion criteria (12 listed)
- Regularly uses antihistamines that have been started or the dose adjusted within the last 30 days.
- Has started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before Screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or is unable to maintain stable dosing throughout the study.
- Is unable to withhold the use of systemic cholinergic secretagogues and oral comfort agents (e.g., OraMoist, MouthKote, Biotene products, etc.) on the morning of each study visit and until 2 hours after dosing at study visits; and is unable to take the last nighttime dose at a standard time throughout the study.
- Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
- Shows evidence of a significant active or ongoing oral infection or other oral conditions (e.g., lichen planus) that, in the opinion of the investigator, might affect the safety of the subject or might exacerbate during study participation.
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 |
|---|---|---|
| P-552Also: P-552 Oral RinseP-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated. | Drug | P-552 on Day 1 and Placebo on Day 2, Placebo on Day 1 and P-552 on Day 2 |
| PlaceboAlso: Vehicle Oral Rinse, Water for InjectionPlacebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated. | Drug | P-552 on Day 1 and Placebo on Day 2, Placebo on Day 1 and P-552 on Day 2 |
Primary outcome
Salivary volume
Time frame: 60 minutes
Salivary Volume
Time frame: 120 minutes
1 secondary outcome
Periotron measurement
Time frame: 15, 30 and 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing P-552 in people with Xerostomia and Sjogren's Syndrome, run by Parion Sciences at 1 site in United States.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 23 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary volume (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2019.