Conditions: Chronic Constipation Constipation
Keywords: Chronic Constipation Abdominal Bloating Linaclotide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 487
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

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: Matching placebo
Intervention descriptions: intervention 1: oral capsule, taken once daily each morning at least 30 minutes before breakfast intervention 2: oral capsule, taken once daily each morning at least 30 minutes before breakfast intervention 3: oral capsule, taken once daily each morning at least 30 minutes before breakfast

Protocol document: