Conditions: Irritable Bowel Syndrome Characterized by Constipation
Keywords: Irritable Bowel Syndrome Constipation Linaclotide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 803
Healthy volunteers: no

Brief summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Detailed description:

Arms:
arm 1: Linaclotide 290 micrograms arm 2: Matching placebo

Interventions: intervention 1: Linaclotide 290 micrograms intervention 2: Matching placebo
Intervention descriptions: intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Protocol document: