Trial · NCT00583531

Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis

NCT00583531, Phase 2, Terminated, 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 Antibiotic-Refractory Pouchitis. Trials, record NCT00583531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583531

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 Antibiotic-Refractory Pouchitis
NCT number: NCT00583531
Status: Terminated
Phases: Phase 2
Enrollment: 2 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
Primary	Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points	4 weeks
Primary	Safety: Any adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 4 weeks of treatment	4 weeks
Secondary	Remission, as defined as a PDAI score of less than 7 points	4 weeks
Secondary	Reduction of PDAI clinical symptom subscore of at least 1 point	4 weeks
Secondary	Reduction of PDAI endoscopic subscore of at least 1 point	4 weeks
Secondary	Reduction of PDAI histology subscore of at least 1 point	4 weeks
Secondary	Need for rescue medication/quantity of antidiarrheal medication used during the last week of the trail compared to usage in the week prior to study entry	4 weeks
Secondary	Quality of Life as measured by the Cleveland Global QoL instrument and Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	4 weeks
Secondary	Significant change in clinical laboratory tests	4 weeks
Secondary	Worsening GI symptoms (diarrhea, abdominal pain, urgency or bleeding) or new GI and extra-GI symptoms (e.g., headache, nausea, vomiting, constipation)	4 weeks

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes0

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.

Papers59

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1335407	BACKGROUND	PubMed
2155847	BACKGROUND	PubMed
2339922	BACKGROUND	PubMed
2693561	BACKGROUND	PubMed
2911318	BACKGROUND	PubMed
2914643	BACKGROUND	PubMed
3039030	BACKGROUND	PubMed
3058838	BACKGROUND	PubMed
3611389	BACKGROUND	PubMed
7639579	BACKGROUND	PubMed

1 to 10 of 59

See all 59 papers

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00583531

GET https://conductscience.org/api/trials/v1/NCT00583531/papers?page=2

API reference For AI assistants