Trial · NCT00583076
Safety and Efficacy of AST-120 in the Treatment of Pouchitis
NCT00583076, Phase 2, Completed, Ocera Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of AST-120 in the Treatment of Pouchitis. Trials, record NCT00583076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of AST-120 in the Treatment of Pouchitis
- NCT number
- NCT00583076
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Ocera Therapeutics
- Conditions
- Pouchitis
- Interventions
- AST-120
- First posted
- 2007-12-31
- Last updated
- 2014-06-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Remission induction as defined by a Pouchitis Disease Activity Index (PDAI) score < 7 (Sandborn et al, Mayo Clin Proc 1994), as well as maintenance of remission over 12 months | 4 weeks induction, 12 months maintenance of remission | |
| Primary | Safety: Any adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product | 4 weeks induction, 12 months maintenance of remission | |
| Secondary | Response defined as a > or = 3 point reduction in the 18-point PDAI scoring system | 4 weeks, weeks 28 and 52 | |
| Secondary | Reduction of PDAI clinical symptom score, range from 0 to 6 (e.g., stoll frequency returns to the normal baseline) | 4 weeks, weeks 28 and 52 | |
| Secondary | Reduction of PDAI endoscopic score, range from 0 to 6 | 4 weeks, weeks 28 and 52 | |
| Secondary | Reduction of PDAI histology score, range from 0 to 6 | 4 weeks, weeks 28 and 52 | |
| Secondary | Need for rescue medication or increased quantity of antidiarrheal medication used during the trial | 4 weeks, weeks 28 and 52 | |
| Secondary | Quality of Life (Cleveland Global Quality of Life [CGQL] and Short Inflammatory Bowel Disease Questionnaire [SIBDQ] | 4 weeks, through 52 weeks | |
| Secondary | Clinical laboratory tests including liver transaminases and alkaline phosphatase | 4 weeks, through 52 weeks | |
| Secondary | Worsening GI symptoms (diarrhea, abdominal pain, urgency or bleeding) or new GI and ex-intestinal systemic symptoms (such as headache, nausea, vomiting, and constipation) | 4 weeks, through 52 weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers36
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00583076
GET https://conductscience.org/api/trials/v1/NCT00583076/papers?page=2