Conditions: Irritable Bowel Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 213
Healthy volunteers: no

Brief summary:
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Detailed description:

Arms:
arm 1: Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks arm 2: Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks arm 3: Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks arm 4: Part A: Placebo capsule every 12 hours for 4 weeks

Interventions: intervention 1: AGN 203818 intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: placebo
Intervention descriptions: intervention 1: Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks intervention 2: Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks intervention 3: Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks intervention 4: Part A: placebo capsule every 12 hours for 4 weeks

Protocol document: