Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: Placebo; Drug: Linaclotide 145 micrograms; Drug: Linaclotide 290 micrograms

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765882

LIN-MD-01

Details and patient eligibility

About

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Enrollment: 633 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
• Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
• Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
• Patient demonstrates continued chronic constipation through Pretreatment Period
• Patient is compliant with IVRS

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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633 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Linaclotide 290 micrograms

Treatment:

Drug: Linaclotide 290 micrograms

2

Experimental group

Description:

Linaclotide 145 micrograms

Treatment:

Drug: Linaclotide 145 micrograms

3

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo