Conditions: Chronic Idiopathic Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1223
Healthy volunteers: no

Brief summary:
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Detailed description:
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.

Arms:
arm 1: 72 μg oral linaclotide, once daily for 12 weeks arm 2: 145 μg oral linaclotide, once daily for 12 weeks arm 3: matching placebo, once daily for 12 weeks

Interventions: intervention 1: Linaclotide intervention 2: Matching Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: