Phase 3
Completed N=839
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)
Source: ClinicalTrials.gov NCT01880424 ↗
Enrolled (actual)
839
Serious AEs
1.7%
Results posted
Sep 2016
Primary outcomePrimary: 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder — 250; 206 Participants — p=0.0010
◆ Published Evidence
Emerging
8citations · ~2 / year
Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.
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).
Linked Publications
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Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01880424) and the linked publication. 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. Informational only — not medical advice.