Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Collaborator: Forest Laboratories
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• Patient has completed a colonoscopy according to the American Gastroenterological Association (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