CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 191 enrolled
Drug / intervention
AST-120drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00321412
NCT00321412Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

Ocera Therapeutics·interventional·Posted May 3, 2006·Updated May 30, 2014

In Brief

A Phase 3 clinical trial evaluating AST-120 for Inflammatory Bowel Disease and Intestinal Fistula. Completed, enrolled 191 participants across 88 sites in 12 countries.

Detailed Summary

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Disease, Intestinal Fistula
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2006
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.2 years ago

Interventions

AST-120drug

oral, sachet, 2 grams three times daily for 8 weeks