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NCT00583531 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
A Phase 2 study, sponsored by Ocera Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00583531: Clinical Trial Phase 2 study, sponsored by Ocera Therapeutics.
NCT00583531 is a Phase 2 study that was terminated before completion, run by Ocera Therapeutics. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583531, a Phase 2 study, was terminated before completion, sponsored by Ocera Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of the study is to assess whether the investigational medication AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An initial group of 10 patients will be enrolled. If there are no serious side effects associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients may be enrolled. Patients will have clinic visits at the start of the study and at week 4. Patients will be checked by phone on a weekly basis for symptom response, compliance and development of side effects. Endoscopies will be performed at the start of the study and at week 4 or early termination.
Interventions
- DRUG AST-120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
Why NCT00583531 stopped before completion
NCT00583531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which AST-120 is the first listed.
NCT00583531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583531 about?
NCT00583531 is a clinical study titled "Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis". This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of ...
What is the current status of trial NCT00583531?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2007-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00583531?
The interventions under investigation include: AST-120 (DRUG).
Who is sponsoring clinical trial NCT00583531?
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 NCT00583531's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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