Conditions: Irritable Bowel Syndrome With Constipation Chronic Constipation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1743
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:
Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Arms:
arm 1: Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.

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: