Phase 3
Completed N=614
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome Characterized by Constipation
Source: ClinicalTrials.gov NCT03573908 ↗
Enrolled (actual)
614
Serious AEs
0.7%
Results posted
Nov 2020
Primary outcomePrimary: Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period — -1.182; -1.898 score on a scale — p=< 0.0001
◆ Published Evidence
Established
▲ Trending
70citations · ~14 / year
Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.
Summary
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
Linked Publications (2)
-
Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.
-
Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period |
-1.182; -1.898 | < 0.0001 sig |
| SECONDARY Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score |
0.0; 0.3; 0.0; 0.7; 0.3; 1.3 | < 0.0001 sig |
| SECONDARY Percentage of 6/12 Week Abdominal Score Responders (Responder Rate) |
23.4; 40.5 | < 0.0001 sig |
| SECONDARY Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period |
-0.490; -0.925; -0.795; -1.423; -0.908; -1.592 | < 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has no clinically significant findings on a physical examination and clinical laboratory tests
- Female patients of childbearing potential must agree to use one of the following methods of birth control:
- Hormonal contraception
- Double-barrier birth control
- Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
- Patient meets protocol criteria for diagnosis of IBS-C
- Patient demonstrates continued IBS-C symptoms 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 (NCT03573908) and the linked publication. 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.