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NCT00583076 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AST-120 in the Treatment of Pouchitis
A Phase 2 study, sponsored by Ocera Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00583076: Completed Phase 2 study, sponsored by Ocera Therapeutics.
NCT00583076 is a Phase 2 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583076, a Phase 2 study, has completed, sponsored by Ocera Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The aim of the study is to assess the safety and efficacy of an investigational agent, AST-120, in treating patients with active pouchitis. This is an open-label trial which means that all patients will receive AST-120 in 2g sachets (packets)three times a day for 4 weeks. All antibiotics, probiotics and nutritional agents must have been discontinued for at least 2 weeks prior to study entry. An initial group of 10 patients will be enrolled. If there are no serious adverse events associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients will be enrolled. In the second group of patients, those patients who are considered responders or who are in remission are eligible to receive open-label AST-120 for as long as response is maintained up to a maximum of 52 weeks. Patients will have clinic visits at the start of the study and at week 4. If continuing on open label AST-120 after week 4, patients will have clinic visits every 12 weeks to assess the continuing safety and efficacy of AST-120. Endoscopies will be performed at the start of the study, week 4, week 28, week 52 or early termination.
Interventions
- DRUG AST-120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00583076 record still lists
NCT00583076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which AST-120 is the first listed.
NCT00583076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583076 about?
NCT00583076 is a clinical study titled "Safety and Efficacy of AST-120 in the Treatment of Pouchitis". The aim of the study is to assess the safety and efficacy of an investigational agent, AST-120, in treating patients with active pouchitis. This is an open-label trial which means that all patients will receive AST-120 in 2g sachets (packets)three times a day for 4 weeks. All antibiotics, probiotics...
What is the current status of trial NCT00583076?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2007-02. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00583076?
The interventions under investigation include: AST-120 (DRUG).
Who is sponsoring clinical trial NCT00583076?
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 NCT00583076's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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