Cough Reflex SensitivityPhase 4NCT02062710
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
A Phase 4 study of Cough Reflex Sensitivity, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough Reflex Sensitivity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 4
- 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
- healthy adult nonsmokers
- onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment
Who cannot join
- smokers
- history of asthma or other respiratory disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Division/Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.
- Conditions
- Cough Reflex Sensitivity
- Being tested
- diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
- Keywords
- cough, cough reflex, capsaicin, diphenhydramine, phenylephrine, dextromethorphan, placebo
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diphenhydramine/phenylephrine/cocoa; dextromethorophan; placeboDrug
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.
diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphanDrug
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.
dextromethorphan; diphenhydramine/phenylephrine/cocoa; placeboDrug
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo
dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoaDrug
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg
placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphanDrug
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg
placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaDrug
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg
| Study group | Role | What they receive |
|---|---|---|
| A, B, then C | Experimental | Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
| A, C, then B | Experimental | Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
| B, A, then C | Experimental | Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
| B, C, then A | Experimental | Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
| C, A, then B | Experimental | Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
| C, B, then A | Experimental | Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. Receives: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cough Reflex Sensitivity to Capsaicin
increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Measured: 2 hours after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cough Reflex SensitivityStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Dicpinigaitis, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062710
- Sponsor's protocol ID
- MMC-IRB-13-10-170
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2014
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dicpinigaitis PV, Dhar S, Johnson A, Gayle Y, Brew J, Caparros-Wanderley W. Inhibition of cough reflex sensitivity by diphenhydramine during acute viral respiratory tract infection. Int J Clin Pharm. 2015 Jun;37(3):471-4. doi: 10.1007/s11096-015-0081-8. Epub 2015 Feb 12.
PubMed 25673148
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
- ClinicalTrials.gov ID
- NCT02062710
- Acronym / sponsor ID
- MMC-IRB-13-10-170
- Conditions
- Cough Reflex Sensitivity
- Keywords
- cough, cough reflex, capsaicin, diphenhydramine, phenylephrine, dextromethorphan, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 28 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A, B, then C | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period. |
| A, C, then B | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period. |
| B, A, then C | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. |
| B, C, then A | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. |
| C, A, then B | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. |
| C, B, then A | Experimental | Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo, Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan, Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo, Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa, Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan, Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaSubjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adult nonsmokers
- onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment
Key exclusion criteria (2 listed)
- smokers
- history of asthma or other respiratory disorders
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 |
|---|---|---|
| diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebodiphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo. | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
| diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphandiphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg. | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
| dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebodextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
| dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoadextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
| placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphanplacebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
| placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaplacebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg | Drug | A, B, then C, A, C, then B, B, A, then C, B, C, then A, C, A, then B, C, B, then A |
Primary outcome
Change in Cough Reflex Sensitivity to Capsaicin
Time frame: 2 hours after study drug administration
increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25673148Dicpinigaitis PV, Dhar S, Johnson A, Gayle Y, Brew J, Caparros-Wanderley W. Inhibition of cough reflex sensitivity by diphenhydramine during acute viral respiratory tract infection. Int J Clin Pharm. 2015 Jun;37(3):471-4. doi: 10.1007/s11096-015-0081-8. Epub 2015 Feb 12.
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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 4 study of Cough Reflex Sensitivity, run by Montefiore Medical Center 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 2 inclusion and 2 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 28 Feb 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 28 Apr 2015). 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 Cough Reflex Sensitivity to Capsaicin (time frame: 2 hours after study drug administration). 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 NCT02062710, which also lists 1 linked publication.
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 28 Feb 2018.