Phase 2
Completed N=420
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome With Constipation
Source: ClinicalTrials.gov NCT00460811 ↗
Enrolled (actual)
420
Serious AEs
0.2%
Results posted
Jan 2013
Primary outcomePrimary: Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period — 2.90; 2.49; 3.61; 2.68 CSBMs per week — p=0.0002
Summary
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period |
2.90; 2.49; 3.61; 2.68; 1.01 | 0.0002 sig |
| SECONDARY CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) |
20; 16; 27; 21; 10 | — |
| SECONDARY Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period |
4.62; 4.36; 4.97; 5.64; 1.68 | — |
| SECONDARY Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period |
1.91; 1.80; 2.28; 2.20; 0.56 | — |
| SECONDARY Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period |
-1.23; -1.20; -1.48; -1.35; -0.71 | — |
| SECONDARY Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period |
-1.33; -1.37; -1.66; -1.49; -0.81 | — |
| SECONDARY Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period |
-0.71; -0.71; -0.90; -0.86; -0.49 | — |
Eligibility Criteria
Inclusion Criteria
- Must not be pregnant or breastfeeding and agree to use birth control;
- Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
- Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
- Demonstrates English fluency and has access to a touch-tone telephone.
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;
- Clinically-significant alarm symptoms;
- Secondary causes of constipation or evacuation disorders;
- Surgery to the gastrointestinal tract;
- Usage of prohibited medications.
Data sourced from ClinicalTrials.gov (NCT00460811). 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.