At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 117 enrolled
Drug / intervention
AST-120 +1 moredrug
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.
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome
In Brief
A Phase 2 clinical trial evaluating AST-120 and Celphere® CP-305 for Irritable Bowel Syndrome. Completed, enrolled 117 participants across 17 sites in 2 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 non-constipating IBS. The study will test whether or not patients receiving AST-120 experience at least a 50% reduction in the number of days with abdominal pain compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesBelgium, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedDec 2007
Primary CompletionMay 2010
Study CompletionJun 2010
TodayJul 2026
First PostedDec 31, 2007
Enrollment StartAug 1, 2007
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.5 years ago
Interventions
AST-120drug
oral, sachet, 2 grams three times daily for 8 weeks
Celphere® CP-305drug
oral, placebo, sachet, 2 grams three times daily for 8 weeks