Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00262132 · ClinicalTrials.gov registry record · Phase 3
Mycophenolate for Pulmonary Sarcoidosis
A Phase 3 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00262132 is a Phase 3 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 20 participants.
The verdict
NCT00262132, a Phase 3 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate for 1 week. If their blood counts are not affected on this dose and they have no significant symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients are followed with multiple study visits. At these visits blood tests are drawn to make sure that there are no significant side effects from mycophenolate. In addition, the patients have a history and physical performed to evaluate the clinical state of their sarcoidosis and to detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for analysis. The patients are evaluated with spirometry, measurements of shortness of breath (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this pilot study will suggest that mycophenolate is a reasonable treatment option for new onset pulmonary sarcoidosis.
Interventions
- DRUG Mycophenolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00262132
The ClinicalTrials.gov registry entry for NCT00262132 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate is the first listed.
NCT00262132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00262132 about?
NCT00262132 is a clinical study titled "Mycophenolate for Pulmonary Sarcoidosis". Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis....
What is the current status of trial NCT00262132?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2003-09. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00262132?
The interventions under investigation include: Mycophenolate (DRUG).
Who is sponsoring clinical trial NCT00262132?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.