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NCT00686855 · ClinicalTrials.gov registry record · Phase 2
Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
A Phase 2 study of Oral Chronic Graft-versus-host Disease, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 5
- Study locations
NCT00686855: Completed Phase 2 study of Oral Chronic Graft-versus-host Disease, sponsored by Brigham and Women's Hospital.
NCT00686855 is a Phase 2 study of Oral Chronic Graft-versus-host Disease that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00686855, a Phase 2 study of Oral Chronic Graft-versus-host Disease, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)
Primary Outcome
Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Tacrolimus
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Children's Hospital Boston - Boston
- Dana-Farber Cancer Institute - Boston
- Beth-Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT00686855 record still lists
NCT00686855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Oral Chronic Graft-versus-host Disease appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00686855 lists 5 locations in 1 state (Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00686855 about?
NCT00686855 is a clinical study titled "Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease". The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)
What is the current status of trial NCT00686855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2008-08. Estimated completion is 2013-03.
What conditions does trial NCT00686855 study?
This clinical trial studies the following conditions: Oral Chronic Graft-versus-host Disease.
What interventions are being tested in trial NCT00686855?
The interventions under investigation include: Dexamethasone (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT00686855?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00686855 being conducted?
This trial has 5 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00686855's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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