Conditions: Chronic Constipation Irritable Bowel Syndrome With Constipation
Keywords: Constipation Chronic Constipation Irritable Bowel Syndrome With Constipation Linaclotide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1559
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Detailed description:

Arms:
arm 1: Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Interventions: intervention 1: Linaclotide
Intervention descriptions: intervention 1: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Protocol document: