Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: Matching Placebo; Drug: Linaclotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291679

MCP-103-309

Details and patient eligibility

About

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Full description

The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.

Enrollment: 1,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has completed a colonoscopy if one is needed 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 CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
• Patient is compliant with daily interactive voice response system (IVRS) calls
• Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

Exclusion criteria

• Patient has history of loose or watery stools
• Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
• 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
• Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,223 participants in 3 patient groups, including a placebo group

72 μg linaclotide

Experimental group

Description:

72 μg oral linaclotide, once daily for 12 weeks

Treatment:

Drug: Linaclotide

145 μg linaclotide

Experimental group

Description:

145 μg oral linaclotide, once daily for 12 weeks

Treatment:

Drug: Linaclotide

Placebo

Placebo Comparator group

Description:

matching placebo, once daily for 12 weeks

Treatment:

Drug: Matching Placebo