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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 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 510 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00679432
The ClinicalTrials.gov registry entry for NCT00679432 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00679432 reports 0 study locations.
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.
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