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Rifaximin in Non-Constipation IBS (TARGET 2)
NCT00724126Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2008
- Primary completion
- Aug 2009
- Countries
- 1
- Sponsor
- Valeant Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- rifaximin
- Conditions
- irritable bowel syndrome (IBS)
01
Overview
Phase 3, randomised, double-blind trial in irritable bowel syndrome (IBS) comparing Rifaximin with Placebo (2 arms). Primary endpoint: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period. Started Jul 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rifaximin
Rifaximin 550 mg TID
Placebo
Placebo TID
03
Who it enrols
Patients with confirmed non-constipation IBS per Rome II criteria. Excludes patients with constipation, type 1 or 2 diabetes, or lactose intolerance not controlled by diet.
04
Endpoints
Primary
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period
Secondary
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period
05
Results
Primary endpoints met
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