Conditions: Constipation Predominant Irritable Bowel Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 356
Healthy volunteers: no

Brief summary:
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.

Detailed description:

Arms:
arm 1: AZD1722 arm 2: AZD1722 arm 3: AZD1722 arm 4: None

Interventions: intervention 1: AZD1722 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: