At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 614 enrolled
Drug / intervention
Linaclotide +1 moredrug
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.
A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
In Brief
A Phase 3 clinical trial evaluating Linaclotide and Placebo for Irritable Bowel Syndrome Characterized by Constipation. Completed, enrolled 614 participants across 79 sites.
Detailed Summary
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAllergan Sales, LLC
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJun 2018
Primary CompletionMar 2019
Study CompletionApr 2019
TodayJul 2026
First PostedJun 29, 2018
Enrollment StartJun 20, 2018
Primary CompletionMar 13, 2019
Study CompletionApr 10, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.0 years ago
Interventions
Linaclotidedrug
Oral capsule
Placebodrug
Matching placebo oral capsule