Phase 3 N=614 Randomized Double-blind Treatment

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Irritable Bowel Syndrome Characterized by Constipation

Bottom Line

View on ClinicalTrials.gov: NCT03573908 ↗

Enrolled (actual)

614

Serious AEs

0.7%

Results posted

Nov 2020

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Linaclotide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ironwood Pharmaceuticals, Inc.
Primary completion: Mar 2019

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03573908). 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.