Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to 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 Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460811

MCP-103-202

Details and patient eligibility

About

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must not be pregnant or breastfeeding and agree to use birth control;
• Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
• Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
• Demonstrates English fluency and has access to a touch-tone telephone.

Exclusion criteria

• Recent history of mushy or watery stools;
• Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
• Clinically-significant alarm symptoms;
• Secondary causes of constipation or evacuation disorders;
• Surgery to the gastrointestinal tract;
• Usage of prohibited medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 5 patient groups, including a placebo group

72 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: Linaclotide Acetate

145 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: Linaclotide Acetate

290 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: Linaclotide Acetate

579 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: Linaclotide Acetate

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo