Phase 3
N=643
Trial of Linaclotide in Patients With Chronic Constipation
Chronic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00730015 ↗Enrolled (actual)
643
Serious AEs
1.2%
Results posted
Jan 2013
Primary outcome: Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 46; 42; 7 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Matching Placebo (Drug); Linaclotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Spontaneous Bowel Movement (CSBM) Overall Responder |
46; 42; 7 | <0.0001 sig |
| SECONDARY 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency |
1.94; 2.04; 0.45 | — |
| SECONDARY 12-Week Spontaneous Bowl Movement (SBM) Frequency |
3.03; 2.98; 1.08 | — |
| SECONDARY 12-week Change in Stool Consistency |
1.85; 1.84; 0.58 | — |
| SECONDARY 12-week Change in Severity of Straining |
-1.12; -1.15; -0.51 | — |
| SECONDARY 12-week Change in Abdominal Discomfort |
-0.49; -0.44; -0.30 | — |
| SECONDARY 12-week Change in Bloating |
-0.46; -0.37; -0.22 | — |
| SECONDARY 12-week Change in Constipation Severity |
-0.90; -0.81; -0.27 | — |
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 dosing 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
Data sourced from ClinicalTrials.gov (NCT00730015). 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.