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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 is a Phase 2 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 19 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00583076
The ClinicalTrials.gov registry entry for NCT00583076 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocera Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AST-120 is the first listed.
NCT00583076 reports 0 study locations.
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.
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