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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome With Constipation

Treatments: Drug: Matching Placebo; Drug: Linaclotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02559206

MCP-103-204

Details and patient eligibility

About

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).

Enrollment: 759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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759 participants in 8 patient groups, including a placebo group

30 μg linaclotide DR1 and placebo

Experimental group

Treatment:

Drug: Linaclotide

100 μg linaclotide DR1 and placebo

Experimental group

Treatment:

Drug: Linaclotide

300 μg linaclotide DR1 and placebo

Experimental group

Treatment:

Drug: Linaclotide

30 μg linaclotide DR2 and placebo

Experimental group

Treatment:

Drug: Linaclotide

100 μg linaclotide DR2 and placebo

Experimental group

Treatment:

Drug: Linaclotide

300 μg linaclotide DR2 and placebo

Experimental group

Treatment:

Drug: Linaclotide

290 μg linaclotide IR and placebo

Experimental group

Treatment:

Drug: Linaclotide

Placebo

Placebo Comparator group

Treatment:

Drug: Matching Placebo