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NCT00321412 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
A Phase 3 study, sponsored by Ocera Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 191
- Enrollment target
NCT00321412: Completed Phase 3 study, sponsored by Ocera Therapeutics.
NCT00321412 is a Phase 3 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 191 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321412, a Phase 3 study, has completed, sponsored by Ocera Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 191 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).
Interventions
- DRUG AST-120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00321412 record still lists
NCT00321412 is an interventional study that assigns participants to a tested intervention. The registered 191 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which AST-120 is the first listed.
NCT00321412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00321412 about?
NCT00321412 is a clinical study titled "Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas". The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of dr...
What is the current status of trial NCT00321412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 191 participants. The study started on 2006-03. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00321412?
The interventions under investigation include: AST-120 (DRUG).
Who is sponsoring clinical trial NCT00321412?
This trial is sponsored by Ocera Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00321412's enrollment target sits among peer trials
191 1402nd of 2000 higher than 599 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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