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NCT01557517 · ClinicalTrials.gov registry record · Phase 2
Clobetasol for Oral Graft-Versus-Host Disease
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01557517: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01557517 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01557517, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: \- Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow transplants. It is the result of the donor cells trying to attack the recipients body. Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause side effects when given as pills or injections. Steroids given in a cream or rinse form, applied directly to the site of the symptoms, can have fewer side effects. However, their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD. Objectives: \- To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host disease. Eligibility: \- Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and other tests before starting the study drug. * Participants will be separated into two groups. One group will receive clobetasol; the other will have a placebo liquid. * Participants will rinse their mouths with the study liquid three times a day after meals for 2 weeks. * After 2 weeks, participants will have another study visit with blood tests and other exams. * After the study visit, all participants will start to use the clobetasol rinse. Those who originally had clobetasol will use the rinse for another 2 weeks. Those who originally had a placebo will use the rinse for 4 weeks. * Participants will have a follow-up exam after the end of treatment....
Primary Outcome
Mucosal changes were assessed by the Oral Mucositis Rating Scale. The primary endpoint was evaluated using the OMRS. Oral tissue changes are rated on a scale of 0-3 compared with normal oral tissue (0-normal/no change, 1-mild change, 2-moderate change, and 3-severe change). Total score is the sum of all OMRS items with a possible range of 0. Total score is the sum of all OMRS items with a possible range of 0-273. Lower score=more normal oral mucosa. There is no standard definition of response in
Interventions
- DRUG Placebo oral rinse
- DRUG Clobetasol Oral Rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-03-28 |
| Est. Completion | 2017-08-24 |
| Phase | Phase 2 |
What the finished NCT01557517 record still lists
NCT01557517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral rinse is the first listed.
NCT01557517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01557517 about?
NCT01557517 is a clinical study titled "Clobetasol for Oral Graft-Versus-Host Disease". Background: \- Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow transplants. It is the result of the donor cells trying to attack the recipients body. Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and painful swallowing. Ste...
What is the current status of trial NCT01557517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-03-28. Estimated completion is 2017-08-24.
What interventions are being tested in trial NCT01557517?
The interventions under investigation include: Placebo oral rinse (DRUG), Clobetasol Oral Rinse (DRUG).
Who is sponsoring clinical trial NCT01557517?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01557517's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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