Phase 3 N=633 Randomized Quadruple-blind Treatment

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

Chronic Constipation

Bottom Line

View on ClinicalTrials.gov: NCT00765882 ↗

Enrolled (actual)

633

Serious AEs

2.2%

Results posted

Jan 2013

Primary outcome: Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 13; 34; 43; 202 participants — p=0.0012

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Linaclotide 290 micrograms (Drug); Linaclotide 145 micrograms (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Spontaneous Bowel Movement (CSBM) Overall Responder	13; 34; 43; 202; 179; 159	0.0012 sig
SECONDARY 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate	0.614; 2.011; 2.653	—
SECONDARY 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate	1.113; 3.466; 3.675	—
SECONDARY 12-Week Stool Consistency	0.572; 1.823; 2.009	—
SECONDARY 12-Week Severity of Straining	-0.554; -1.141; -1.208	—
SECONDARY 12-Week Abdominal Discomfort	-0.271; -0.455; -0.485	—
SECONDARY 12-Week Bloating	-0.244; -0.432; -0.485	—
SECONDARY 12-Week Constipation Severity	-0.306; -0.908; -0.954	—

Summary

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

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00765882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.