Phase 3
N=805
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome With Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00938717 ↗Enrolled (actual)
805
Serious AEs
1.4%
Results posted
Jan 2013
Primary outcome: Primary: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks — 12; 51 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Linaclotide or Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks |
12; 51 | <0.0001 sig |
| PRIMARY Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks |
20; 72 | <0.0001 sig |
| PRIMARY Abdominal Pain Responder, 9 Out of 12 Weeks |
79; 156 | <0.0001 sig |
| PRIMARY Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks |
56; 135 | <0.0001 sig |
| SECONDARY 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency |
0.70; 2.24 | — |
| SECONDARY 12-Week Spontaneous Bowl Movement (SBM) Frequency |
1.31; 4.02 | — |
| SECONDARY 12-Week Change in Stool Consistency |
0.61; 1.91 | — |
| SECONDARY 12-Week Change in Severity of Straining |
-0.66; -1.24 | — |
| SECONDARY 12-Week Change in Abdominal Pain Score |
-1.07; -1.85 | — |
| SECONDARY 12-Week Change in Abdominal Discomfort |
-1.10; -1.94 | — |
| SECONDARY 12-Week Change in Bloating |
-1.03; -1.91 | — |
| SECONDARY Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment |
91; 191 | — |
| SECONDARY Abdominal Pain Responder for 6 Out of 12 Weeks |
139; 196 | — |
| SECONDARY 12-Week Percent of Abdominal Pain-free Days |
4.83; 10.49 | — |
Summary
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
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 diagnosis of IBS-C
- Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
- 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 (NCT00938717). 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.