Phase 3
N=1,223
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02291679 ↗Enrolled (actual)
1,223
Serious AEs
0.7%
Results posted
May 2017
Primary outcome: Primary: Percentage of 12-Week CSBM Overall Responders — 4.7; 13.4; 95.3; 86.6 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Linaclotide (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of 12-Week CSBM Overall Responders |
4.7; 13.4; 95.3; 86.6 | < 0.0001 sig |
| SECONDARY Change From Baseline in 12-Week CSBM Frequency Rate |
0.884; 1.725 | < 0.0001 sig |
| SECONDARY Change From Baseline in 12-Week SBM Frequency Rate |
1.329; 2.366 | < 0.0001 sig |
| SECONDARY Change From Baseline in 12-Week Stool Consistency Score |
1.065; 1.693 | < 0.0001 sig |
| SECONDARY Change From Baseline in 12-Week Straining Score |
-0.789; -1.118 | < 0.0001 sig |
| SECONDARY Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation) |
7.1; 17.2; 92.9; 82.8 | 0.0008 sig |
| SECONDARY Percentage of Month 1 CSBM Responders |
6.2; 14.8; 93.8; 85.2 | < 0.0001 sig |
| SECONDARY Percentage of Month 2 CSBM Responders |
9.5; 18.7; 90.5; 81.3 | 0.0002 sig |
| SECONDARY Percentage of Month 3 CSBM Responders |
14.2; 20.2; 85.8; 79.8 | 0.0342 sig |
| SECONDARY Change From Baseline in 12-Week Abdominal Bloating |
-1.052; -1.372 | 0.0063 sig |
| SECONDARY Change From Baseline in 12-Week Abdominal Discomfort |
-1.146; -1.323 | 0.1028 |
Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants 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 if one is needed 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 CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
- Patient is compliant with daily interactive voice response system (IVRS) calls
- Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.
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
- Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Data sourced from ClinicalTrials.gov (NCT02291679). 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.