Who is sponsoring NCT00583128?

NCT00583128 is sponsored by Ocera Therapeutics.

What condition does NCT00583128 study?

NCT00583128 studies Irritable Bowel Syndrome.

What drugs are being tested in NCT00583128?

Interventions: AST-120, Celphere® CP-305.

What is the status of NCT00583128?

NCT00583128 is currently COMPLETED.

Last reviewed 2014-06-02 · How we verify

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

NCT00583128 Phase 2 COMPLETED

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.

Details

Lead sponsor	Ocera Therapeutics
Phase	Phase 2
Status	COMPLETED
Enrolment	117
Start date	2007-08
Completion	2010-06

Conditions

Irritable Bowel Syndrome

Interventions

AST-120
Celphere® CP-305

Primary outcomes

Percent of patients who achieve at least a 50% reduction in the number of days with abdominal pain during the final 2 weeks of the double-blind treatment course. — Eight weeks
Safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course. — 8 weeks

Countries

United States, Belgium