Conditions: Chronic Constipation
Keywords: Constipation Chronic Constipation Linaclotide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 633
Healthy volunteers: no

Brief summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Detailed description:

Arms:
arm 1: Linaclotide 290 micrograms arm 2: Linaclotide 145 micrograms arm 3: Matching placebo

Interventions: intervention 1: Linaclotide 290 micrograms intervention 2: Linaclotide 145 micrograms intervention 3: 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 intervention 3: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Protocol document: