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NCT00451867 · ClinicalTrials.gov registry record · Phase 3
A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
NCT00451867 is a Phase 3 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 210 participants.
The verdict
NCT00451867, a Phase 3 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis. CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants work in the body by reducing the immune system's ability to produce certain reactions that can cause inflammation. In some people, the inflammation produced by their immune system can damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant. When used in combination with other drugs, CellCept helps to prevent the rejection of the transplanted organ and is used widely in patients who have received kidney, liver and heart transplants. CellCept is also frequently used but not FDA approved for the treatment of severe rheumatoid arthritis which is a disease caused when the body's immune system acts against healthy tissues in the joints. Due to its special activity, CellCept may be useful in treating certain inflammatory diseases or conditions like interstitial cystitis.
Interventions
- DRUG Placebo
- DRUG Mycophenolate Mofetil
- DRUG Mycofenolate Mofetil (MMF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00451867
The ClinicalTrials.gov registry entry for NCT00451867 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00451867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00451867 about?
NCT00451867 is a clinical study titled "A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .". The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis. CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants work in the body ...
What is the current status of trial NCT00451867?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2007-03. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00451867?
The interventions under investigation include: Placebo (DRUG), Mycophenolate Mofetil (DRUG), Mycofenolate Mofetil (MMF) (DRUG).
Who is sponsoring clinical trial NCT00451867?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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