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NCT00075023 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00075023 is a Phase 2 study that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 10 participants.
The verdict
NCT00075023, a Phase 2 study, was terminated before completion, sponsored by National Institute of Nursing Research (NINR).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study was designed to be conducted in 2 parts. The first part is a pilot study to test the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who have developed oral chronic graft-versus-host-disease (cGVHD)-related ulcerative stomatitis following allogeneic bone marrow/peripheral blood stem cell transplant (HSCT). Chronic GVHD may be related to increased levels of a cytokine called TNF-alpha (TNFa) following HSCT. Thalidomide's anti-inflammatory effects may lower TNFa levels, lead to healing of these oral ulcers, and decrease oral pain. If the pilot study is successful, the second part of the study will be done. This will test the effects of a 0.1% (20mg) thalidomide mouthwash in treating oral cGVHD-related stomatitis in patients following allogeneic HSCT. Applying thalidomide directly to the GVHD-related mouth ulcer in gel form or to the entire oral cavity in mouthwash form rather than taking it in pill form may reduce the amount of drug that enters the blood stream and cause less side effects. In the pilot study, participants will be randomly assigned to receive thalidomide gel 20mg or placebo (identical gel with no thalidomide) to use 4 times a day for 4 weeks. In the mouthwash study, participants will be randomly assigned to receive 0.1% 20mg thalidomide mouthwash or placebo (identical mouth rinse with no thalidomide) to use 4 times a day for 4 weeks. Participants will undergo the following procedures before beginning experimental treatment, then once a week for 4 weeks, and then approximately 8 weeks after the first visit: * Interview about current medications and use of alcohol and cigarettes * Self-report of mouth and throat pain * Oral examination for stomatitis rating, and oral ulcer(s) measurement * Quality of life questionnaire (repeated only at week 8 of the study) * Mouth photography to measure and record the oral ulcer response to treatment * Saliva sampling to look for proinflammatory cytokines (small proteins)
Interventions
- DRUG Placebo Gel
- DRUG Thalidomide Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2003-12 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00075023
The ClinicalTrials.gov registry entry for NCT00075023 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Gel is the first listed.
NCT00075023 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00075023 about?
NCT00075023 is a clinical study titled "Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis". This study was designed to be conducted in 2 parts. The first part is a pilot study to test the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who have developed oral chronic graft-versus-host-disease (cGVHD)-related ulcerative stomatitis following allogeneic bone...
What is the current status of trial NCT00075023?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2003-12. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00075023?
The interventions under investigation include: Placebo Gel (DRUG), Thalidomide Gel (DRUG).
Who is sponsoring clinical trial NCT00075023?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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