Phase 3 N=839 Randomized Double-blind Treatment

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Irritable Bowel Syndrome With Constipation (IBS-C)

Bottom Line

View on ClinicalTrials.gov: NCT01880424 ↗

Enrolled (actual)

839

Serious AEs

1.7%

Results posted

Sep 2016

Primary outcome: Primary: 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder — 250; 206 Participants — p=0.0010

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Linaclotide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder	250; 206	0.0010 sig
PRIMARY 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder	132; 65	<0.0001 sig
SECONDARY Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate	1.94; 0.97	—
SECONDARY Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate	2.96; 1.51	—
SECONDARY Change From Baseline in 12-week Stool Consistency	1.51; 0.82	—
SECONDARY Change From Baseline in 12-week Severity of Straining	-1.02; -0.69	—
SECONDARY Change From Baseline in 12-week Abdominal Bloating	-1.50; -0.94	—
SECONDARY Change From Baseline in 12-week Abdominal Pain	-1.56; -1.07	—
SECONDARY Change From Baseline in 12-week Abdominal Discomfort	-1.46; -0.98	—

Summary

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Eligibility Criteria

Inclusion Criteria

Patient has signed an Informed Consent Form(ICF).
Patient Must not be pregnant or breastfeeding and agree to use birth control
Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

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
Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
Surgery to the gastrointestinal tract
Usage of prohibited medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01880424). 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.