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NCT00391170 · ClinicalTrials.gov registry record · Phase 2
Dexamethasone to Prevent Oral Chronic Graft-versus-Host Disease
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT00391170 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 62 participants.
The verdict
NCT00391170, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the donor cells attacking the transplant recipient's tissues. In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores. Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only corticosteroid available that can be used as a mouth rinse. Patients 12 years of age or older who have received a stem cell transplant may be eligible to participate if they are enrolled within 70 to 90 days of their transplant. Candidates are screened with a medical history and oral exam. Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a solution that looks and tastes like the dexamethasone rinse but has no active medication). They undergo the following procedures: Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution or placebo three times a day for 3 months. Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study drug for the following procedures: * Oral exam (before starting treatment and at each visit). * Photographs of the mouth (before starting treatment and at 3 months). * Biopsy from inside the cheek (before starting treatment). The inside of the cheek is numbed and a small piece of tissue is removed for examination by a pathologist. * Saliva sample collection (before starting treatment). * Blood draw (before starting treatment and at each visit). * Quality-of-life questionnaires (before starting treatment and at 3 months). * Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and at each visit). * Review of medications (at each visit). * ACTH stimulation test to evaluate adrenal glan
Interventions
- DRUG Placebo
- DRUG Topical Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2006-11-24 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00391170
The ClinicalTrials.gov registry entry for NCT00391170 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00391170 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00391170 about?
NCT00391170 is a clinical study titled "Dexamethasone to Prevent Oral Chronic Graft-versus-Host Disease". This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the don...
What is the current status of trial NCT00391170?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2006-11-24. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT00391170?
The interventions under investigation include: Placebo (DRUG), Topical Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT00391170?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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