NCT00765999

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: 1,559 (actual)
• Sponsor: Forest Laboratories · 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).

Conditions

• Chronic Constipation
• Irritable Bowel Syndrome With 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: 2008-10-31
• Primary completion: 2012-01-31
• Completion: 2012-01-31
• First posted: 2008-10-03
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

118 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study