NCT00730171

An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,743 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Irritable Bowel Syndrome With Constipation
• Chronic Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide	Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-08-08
• Last updated: 2018-02-19
• Results posted: 2018-02-19

Locations

116 sites across 1 country: United States

Regulatory

• FDA-regulated drug study