At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,559 enrolled
Drug / intervention
Linaclotidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
In Brief
A Phase 3 clinical trial evaluating Linaclotide for Chronic Constipation and Irritable Bowel Syndrome With Constipation. Completed, enrolled 1,559 participants across 118 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
CollaboratorsIronwood Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartOct 2008
Primary CompletionJan 2012
TodayJul 2026
First PostedOct 3, 2008
Enrollment StartOct 31, 2008
Primary CompletionJan 31, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.7 years ago
Interventions
Linaclotidedrug
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.