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NCT00001599 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Thalidomide to Treat Sjogren's Syndrome
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00001599 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 28 participants.
The verdict
NCT00001599, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and salivary glands, causing dry mouth and dry eyes. Thalidomide has shown promise in treating other autoimmune disorders, such as rheumatoid arthritis and systemic lupus erythematosus. Women with Sjogren's syndrome who have dry eyes and dry mouth may be eligible for this study. Women of childbearing potential will not be considered for participation because of severe birth defects associated with thalidomide. Also, since Sjogren's syndrome affects many fewer men than women, men are excluded from this pilot study because they would be too few in number to assess as a separate group. Candidates will be screened with a medical history, physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy test. Tests will also be done to measure the conduction of electrical impulses along the nerves and to evaluate dryness of the eyes. Participants will be randomly assigned to take either thalidomide or a placebo (look-alike pill with no active ingredient). The thalidomide dosage will be increased gradually from a starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age who have had a tubal ligation or longstanding infertility will have a pregnancy test every 2 or 4 weeks. Participants will come to the clinic at the first study visit and again at weeks 4, 8 and 12 for some or all of the following procedures: * Patient assessment of dry mouth (rated on a scale from "worst ever" to "best ever" * Patient assessment of dry eyes (rated on a scale from "worst ever" to "best ever" * Patient health questionnaire and disease assessment rating * Saliva collection * Rose-Bengal or other dye tests for dryness - examination of the eyes under a bright light following administration of drops containing a dye * Schirmer's I test for dryness - placement
Interventions
- DRUG Thalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 1997-05 |
| Est. Completion | 2002-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001599
The ClinicalTrials.gov registry entry for NCT00001599 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Thalidomide is the first listed.
NCT00001599 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001599 about?
NCT00001599 is a clinical study titled "Pilot Study of Thalidomide to Treat Sjogren's Syndrome". This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and salivary glands, causing dry mouth and dry eyes. Thalidomide has shown promise in treating other autoimmune disorders,...
What is the current status of trial NCT00001599?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 1997-05. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00001599?
The interventions under investigation include: Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00001599?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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