Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Recruiting in Palo Alto (17 mi)
+96 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Ironwood Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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).
Research Team
JM
Jeffrey M. Johnston, MD, FACP
Principal Investigator
Ironwood Pharmaceuticals, Inc.
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
See 2 more
Treatment Details
Interventions
- Linaclotide (Guanylate Cyclase-C Agonist)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 290 μg LinaclotideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Linaclotide is already approved in Canada for the following indications:
Approved in Canada as Linzess for:
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ironwood Investigational SiteMiami, FL
Ironwood Investigational SiteTraverse City, MI
Ironwood Investigational SiteTroy, MI
Ironwood Investigational SiteHarrisburg, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Ironwood Pharmaceuticals, Inc.
Lead Sponsor
Trials
42
Patients Recruited
17,100+
Forest Laboratories
Industry Sponsor
Trials
338
Patients Recruited
89,200+
Founded
1956
Headquarters
New York City, USA
Known For
Depression Medications
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