Phase 2
N=532
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome With Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02559206 ↗Enrolled (actual)
532
Serious AEs
0.4%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo — -1.370; -1.938; -1.667; -1.656 score on a scale — p=0.0839
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Linaclotide (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo |
-1.370; -1.938; -1.667; -1.656; -2.140 | 0.0839 |
| PRIMARY Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo |
-1.370; -1.938; -1.825; -1.669; -1.628 | 0.0839 |
| PRIMARY Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo |
1.115; 2.107; 1.163; 1.414; 1.776 | 0.0110 sig |
| PRIMARY Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo |
1.115; 2.107; 1.275; 1.019; 0.869 | 0.0110 sig |
| PRIMARY Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo |
14; 21; 18; 17; 26; 52 | 0.1663 |
| PRIMARY Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo |
14; 21; 16; 16; 14; 52 | 0.1663 |
Summary
The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).
Eligibility Criteria
Inclusion Criteria
- Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
- Patient has no clinically significant findings on a physical examination and clinical laboratory tests
- Patient meets protocol criteria for diagnosis of IBS-C
- Patient demonstrates continued IBS-C through Pretreatment Period
- Patient maintains a minimum level of compliance with daily diary
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 (NCT02559206). 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.