Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Treatments: Drug: Linaclotide 290 micrograms; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00948818

LIN-MD-31

Details and patient eligibility

About

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Enrollment: 803 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:

  1. Relieved with defecation
  2. Onset associated with a change in frequency of stool
  3. Onset associated with a change in form (appearance) of stool

• Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs

• Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)

• Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion criteria

• Patient has history of loose or watery stools for >25% of BMs
• Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
• Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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803 participants in 2 patient groups, including a placebo group

Linaclotide

Experimental group

Description:

Linaclotide 290 micrograms

Treatment:

Drug: Linaclotide 290 micrograms

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Matching placebo