MedTrace Logo

Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

NCT00583128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2014-06-18

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

AST-120

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

DRUG

Celphere® CP-305

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

Sponsors & Collaborators

  • Ocera Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jan Tack, MD · University of Leuven, Department of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583128 on ClinicalTrials.gov