NeoplasmPhase 1/2NCT02434146
Topical Phenylephrine Solution in Preventing Oral Mucosa in Bone Marrow Transplant Patients Receiving Cyclophosphamide and Total Body Radiation Therapy
A Phase 1/2 study testing Topical Phenylephrine Solution in people with Neoplasm and Oral Mucosa, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Oral Mucosa, Transplant-Related Disorder
- What is being tested?
- Topical Phenylephrine Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2015to 25 Jan 2017
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be planning to receive a conditioning regimen for stem cell transplant (SCT) consisting of cyclophosphamide and total body irradiation and must meet inclusion criteria for SCT which include:
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Patients must have no evidence of active infections at the time of transplantation
- Patients must be human immunodeficiency virus (HIV) non-reactive
- Females of childbearing potential must not be pregnant or breastfeeding on admission for conditioning for SCT and a pregnancy test will be required for all females of child-bearing potential
- Patients must have a pre-transplant multi-organ assessment with the following outcome:
Show all 13Show fewer
- A resting ejection fraction of 50% or greater which increases with exercise as demonstrated by resting/exercise multigated acquisition (MUGA)
- A forced expiratory volume in one second (FEV1) of 60% or greater, a diffusion capacity of 50% or greater, and a oxygen partial pressure (PO2) of 80 mm mercury (Hg) or greater on pulmonary function testing
- A serum creatinine of equal or less than 2.0mg/Dl and a creatinine clearance of 50 mL/min or greater on 24 hour urine collection
- A total bilirubin of less than 2.5 mg/dL, unless these values are due to underlying hematologic malignancy
- An aspartate aminotransferase (AST) less than 2 times the upper limit of normal, unless these values are due to underlying hematologic malignancy
- Be able to tolerate topical application of phenylephrine to the oral mucosa
- All patients must sign a written informed consent
Who cannot join
- Open or unhealed wounds or ulcers in the oral cavity
- Current use or use within past two weeks of an monoamine oxidase inhibitor (MAOI)
- Primary or secondary tumor in the oral cavity
- Known allergy to phenylephrine
- Uncontrolled hypertension (defined as blood pressure in adults > 150/95)
- Patients on anti-hypertensive medications are eligible if blood pressure is controlled
Show all 21Show fewer
- Enrollment in any other mucositis prevention study from screening up to day 45 post-stem cell transplant
- Patients who are not eligible to receive SCT with cyclophosphamide and total body irradiation (TBI) conditioning because they do not meet transplant criteria are also not eligible for this phenylephrine study
- General exclusion criteria for transplant include:
- Patients who have angina and/or congestive heart failure requiring treatment, or who have had a myocardial infarction within the past year
- Patients who have had any complication that makes the risk of death during transplantation from non-malignant causes greater than the risk of relapse
- Patients who have any active infection; if the infection is successfully treated, the patient may be reconsidered for transplantation at a later date
- Patients with diabetes who are not controlled by medical management will be ineligible
- Psychiatric illness requiring psychiatric counseling or medical intervention other than antidepressant medications may make an individual ineligible and will be considered on a case-by-case basis
- Psychosocial assessment by the bone marrow transplant team may identify individuals for whom this form of therapy may be contraindicated; these decisions will be based upon estimated adequacy of patient support systems and prediction of patient's compliance with medications, required diagnostic procedures, and/or follow-up care
- Patients who have an ECOG performance status of greater than 2
- Patients who have decreased pulmonary function due to any disorder as demonstrated by a diffusion capacity of less than 50% of predicted, a FEV1 of less than 60% of predicted, or a PO2 of less than 80mmHg on pulmonary function testing
- Patients who have a resting ejection fraction of less than 50%
- Patients who have renal disease as demonstrated by a serum creatinine clearance of greater than 2.0 mg/dL and/or a creatinine clearance of less than 50 mL/min
- Patients who are pregnant or breast feeding at the time of admission for conditioning
- Any mental or physical condition, in the opinion of the principal investigator (PI) or PI designee, which could interfere with the ability of the subject to understand or adhere to the requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase I/IIa Safety and Efficacy Study of Topical Phenylephrine Applied to Oral Mucosa in Bone Marrow Transplant Patients Receiving Cytoxan Plus Total Body Irradiation
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and total body radiation prior to undergoing a bone marrow transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of phenylephrine (topical phenylephrine solution) applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of phenylephrine applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
III. To evaluate the efficacy of phenylephrine applied topically to the oral mucosa in preventing and/or decreasing severity of oral mucositis in bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
OUTLINE: This is a phase I, dose-escalation study of topical phenylephrine solution followed by a phase II study.
Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
After completion of study treatment, patients are followed up weekly for 2 weeks and then at 3 months.
- Conditions
- Neoplasm, Oral Mucosa, Transplant-Related Disorder
- Being tested
- Topical Phenylephrine Solution
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Phenylephrine SolutionDrug
Given topically via spray
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (topical phenylephrine solution) | Experimental | Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment. Receives: Drug: Topical Phenylephrine Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) for the Oral Mucositis Severity
The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.
Measured: Up to 3 months
Duration of Grade 2 Oral Mucositis
If the grade 2 oral mucositis has not been resolved (to a grade < 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Measured: Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months
Duration of Grade 3 Oral Mucositis
If the grade 3 oral mucositis has not been resolved (to a grade < 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Measured: Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months
Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy
If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade >= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.
Measured: Up to 3 months
Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.
Measured: Up to 3 months
Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity
Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa
Measured: During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
Recommended Phase IIa Dose
The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.
Measured: During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
Time to Onset of Grade 2 Oral Mucositis
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Measured: Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months
Time to Onset of Grade 3 Oral Mucositis
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Measured: Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start14 May 2015
- Primary completion27 Apr 2016
- Study completion25 Jan 2017
Why it stopped: A company in China has decided to license the product
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.
- Other trials for NeoplasmStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margo L. Hoover-Regan, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434146
- Sponsor's protocol ID
- UW14068
- Other IDs
- NCI-2015-00576, 2015-0062, A536700, SMPH\PEDIATRICS\PEDIATRICS
- Status last verified
- Sep 2017
- First submitted
- 24 Apr 2015
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Safety and Efficacy Study of Topical Phenylephrine Applied to Oral Mucosa in Bone Marrow Transplant Patients Receiving Cytoxan Plus Total Body Irradiation
- ClinicalTrials.gov ID
- NCT02434146
- Acronym / sponsor ID
- UW14068
- Conditions
- Neoplasm, Oral Mucosa, Transplant-Related Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A company in China has decided to license the product
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 14 May 2015
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 27 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and total body radiation prior to undergoing a bone marrow transplant.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of phenylephrine (topical phenylephrine solution) applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of phenylephrine applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
III. To evaluate the efficacy of phenylephrine applied topically to the oral mucosa in preventing and/or decreasing severity of oral mucositis in bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.
OUTLINE: This is a phase I, dose-escalation study of topical phenylephrine solution followed by a phase II study.
Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
After completion of study treatment, patients are followed up weekly for 2 weeks and then at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (topical phenylephrine solution) | Experimental | Drug: Topical Phenylephrine SolutionPatients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be planning to receive a conditioning regimen for stem cell transplant (SCT) consisting of cyclophosphamide and total body irradiation and must meet inclusion criteria for SCT which include:
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Patients must have no evidence of active infections at the time of transplantation
- Patients must be human immunodeficiency virus (HIV) non-reactive
- Females of childbearing potential must not be pregnant or breastfeeding on admission for conditioning for SCT and a pregnancy test will be required for all females of child-bearing potential
Key exclusion criteria (21 listed)
- Open or unhealed wounds or ulcers in the oral cavity
- Current use or use within past two weeks of an monoamine oxidase inhibitor (MAOI)
- Primary or secondary tumor in the oral cavity
- Known allergy to phenylephrine
- Uncontrolled hypertension (defined as blood pressure in adults > 150/95)
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 |
|---|---|---|
| Topical Phenylephrine SolutionGiven topically via spray | Drug | Supportive care (topical phenylephrine solution) |
Primary outcome
Area Under the Curve (AUC) for the Oral Mucositis Severity
Time frame: Up to 3 months
The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.
Duration of Grade 2 Oral Mucositis
Time frame: Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months
If the grade 2 oral mucositis has not been resolved (to a grade < 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Duration of Grade 3 Oral Mucositis
Time frame: Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months
If the grade 3 oral mucositis has not been resolved (to a grade < 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.
Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy
Time frame: Up to 3 months
If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade >= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.
Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 3 months
Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.
Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity
Time frame: During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa
Recommended Phase IIa Dose
Time frame: During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.
The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.
Time to Onset of Grade 2 Oral Mucositis
Time frame: Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Time to Onset of Grade 3 Oral Mucositis
Time frame: Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months
Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Related trials for Neoplasm
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
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.
Margo L. Hoover-Regan principal investigator
University of Wisconsin, Madison
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 Topical Phenylephrine Solution in people with Neoplasm and Oral Mucosa, run by University of Wisconsin, Madison 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 13 inclusion and 21 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 9 Dec 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?
Yes. Results are posted in the registry (first posted 27 Apr 2017). 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?
Area Under the Curve (AUC) for the Oral Mucositis Severity (time frame: Up to 3 months). The study lists 9 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 9 Dec 2019.