Trial · NCT04227314
Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
NCT04227314, Phase 3, Recruiting, University Hospital, Rouen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis. Trials, record NCT04227314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04227314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
- NCT number
- NCT04227314
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 134 participants, estimated
- Lead sponsor
- University Hospital, Rouen
- Conditions
- Recurrent Aphtous Stomatitis
- Interventions
- Apremilast, Placebo oral tablet
- First posted
- 2020-01-13
- Last updated
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Presence of oral ulcer during clinical examination | Week 12 | Presence or absence of oral ulcer |
| Primary | Presence of oral ulcer during clinical examination | Week 14 | Presence or absence of oral ulcer |
| Secondary | Number of oral ulcer during clinical examination | Week 12 | Mean cumulative number of oral ulcers at the Week 12 evaluation |
| Secondary | Number of oral ulcer during clinical examination | Week 14 | Mean cumulative number of oral ulcers at the Week 14 evaluation |
| Secondary | Difference from baseline in quality of life | Week 14 | quality of life will be evaluated using SF36 |
| Secondary | Occurrence since baseline of severe and adverse events | Week 14 | |
| Secondary | Occurrence since baseline of non-severe adverse events | Week 14 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04227314
GET https://conductscience.org/api/trials/v1/NCT04227314/registered