A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Completed
• Trial end date: 2019-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Collaborator: Allergan Sales, LLC
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• Patient has no clinically significant findings on a physical examination and clinical laboratory tests

• Female patients of childbearing potential must agree to use one of the following methods of birth control:

1. Hormonal contraception

2. Double-barrier birth control

3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

• Patient meets protocol criteria for diagnosis of IBS-C

• Patient demonstrates continued IBS-C symptoms 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