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) (D5630C00001)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Treatments: Drug: Linaclotide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01880424

ICP-103-307

Details and patient eligibility

About

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).

Enrollment: 1,722 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has signed an Informed Consent Form(ICF).
2. Patient Must not be pregnant or breastfeeding and agree to use birth control
3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
4. 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
5. 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

1. Recent history of mushy or watery stools
2. Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
3. Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
4. Surgery to the gastrointestinal tract
5. Usage of prohibited medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,722 participants in 2 patient groups, including a placebo group

controlled arm

Placebo Comparator group

Treatment:

Drug: Placebo

treatment arm

Experimental group

Treatment:

Drug: Linaclotide