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NCT00679432 · ClinicalTrials.gov registry record · Phase 3
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
NCT00679432: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT00679432 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00679432, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
Study Summary
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.
Primary Outcome
Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Interventions
- DRUG Placebo
- PROCEDURE Blood sampling, endoscopy
- DRUG budesonide-MMX® 6 mg
- DRUG budesonide-MMX® 9 mg
- DRUG Asacol® 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00679432 record still lists
NCT00679432 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00679432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00679432 about?
NCT00679432 is a clinical study titled "(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis". The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.
What is the current status of trial NCT00679432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00679432?
The interventions under investigation include: Placebo (DRUG), Blood sampling, endoscopy (PROCEDURE), budesonide-MMX® 6 mg (DRUG), budesonide-MMX® 9 mg (DRUG), Asacol® 400 mg (DRUG).
Who is sponsoring clinical trial NCT00679432?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00679432's enrollment target sits among peer trials
510 729th of 2000 higher than 1,264 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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