Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome with constipation
Treatments linaclotide, matching placebo
Phase phase 2
Sponsor Ironwood Pharmaceuticals, Inc.
Collaborator Forest Laboratories
Start date October 2015
End date November 2016
Trial size 532 participants
Trial identifier NCT02559206, MCP-103-204

Summary

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Experimental)
linaclotide
Oral, once daily
(Placebo Comparator)
matching placebo
Oral, once daily

Primary Outcomes

Measure
The Weekly Change from Baseline in Abdominal Pain
time frame: Change from Baseline to Week 12
The Weekly Change from Baseline Complete Spontaneous Bowel Movement (CSBM) Frequency
time frame: Change from Baseline to Week 12
6/12 Week Abdominal Pain and Constipation (APC) +1 Responder
time frame: Change from Baseline to Week 12

Secondary Outcomes

Measure
6/12 Week CSBM +1 Responder
time frame: Change from Baseline to Week 12
6/12 Week Abdominal Pain Responder
time frame: Change from Baseline to Week 12
Weekly CSBM +1 Responder
time frame: Change from Baseline to Week 12
Weekly Abdominal Pain Responder
time frame: Change from Baseline to Week 12
Weekly APC +1 Responder
time frame: Change from Baseline to Week 12
Change from Baseline in 12-week Abdominal Pain
time frame: Change from Baseline to Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings - Patient has no clinically significant findings on a physical examination and clinical laboratory tests - Patient meets protocol criteria for diagnosis of IBS-C - Patient demonstrates continued IBS-C through Pretreatment Period - Patient maintains a minimum level of compliance with daily diary Exclusion Criteria: - Patient has history of loose or watery stools - Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain - Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility - Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Additional Information

Official title A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Ironwood Pharmaceuticals, Inc..