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NCT00400400 · ClinicalTrials.gov registry record · Phase 4
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
NCT00400400: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00400400 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 400 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400400, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
Study Summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).
Primary Outcome
Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Scor
Interventions
- DRUG Mycophenolate mofetil
- DRUG Enteric-coated mycophenolate sodium (EC-MPS)
- DRUG Placebo to mycophenolate sodium
- DRUG Placebo to mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2006-10 |
| Phase | Phase 4 |
What the finished NCT00400400 record still lists
NCT00400400 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate mofetil is the first listed.
NCT00400400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400400 about?
NCT00400400 is a clinical study titled "Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance". Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of ...
What is the current status of trial NCT00400400?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2006-10.
What interventions are being tested in trial NCT00400400?
The interventions under investigation include: Mycophenolate mofetil (DRUG), Enteric-coated mycophenolate sodium (EC-MPS) (DRUG), Placebo to mycophenolate sodium (DRUG), Placebo to mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00400400?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400400's enrollment target sits among peer trials
400 211th of 2000 higher than 1,784 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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