Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291679
• Other study ID #: MCP-103-309
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2014
• Last updated: August 1, 2016
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1223
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has completed a colonoscopy if one is needed according to the 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 per week and reports one or more of the following during = 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation

• Patient demonstrates continued chronic idiopathic constipation through Pretreatment Period

• Patient is compliant with daily IVRS (interactive voice response system) calls

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Linaclotide
Oral, once daily
• Matching Placebo
Oral, once daily

Locations

Country	Name	City	State
United States	Ironwood Investigational Site	Anaheim	California
United States	Ironwood Investigational Site	Anderson	South Carolina
United States	Ironwood Investigational Site	Asheville	North Carolina
United States	Ironwood Investigational Site	Atlanta	Georgia
United States	Ironwood Investigational Site	Baltimore	Maryland
United States	Ironwood Investigational Site	Bastrop	Louisiana
United States	Ironwood Investigational Site	Beaumont	Texas
United States	Ironwood Investigational Site	Boston	Massachusetts
United States	Ironwood Investigational Site	Boynton Beach	Florida
United States	Ironwood Investigational Site	Bozeman	Montana
United States	Ironwood Investigational Site	Bristol	Connecticut
United States	Ironwood Investigational Site	Bristol	Tennessee
United States	Ironwood Investigational Site	Brooklyn	New York
United States	Ironwood Investigational Site	Chandler	Arizona
United States	Ironwood Investigational Site	Charlotte	North Carolina
United States	Ironwood Investigational Site	Chattanooga	Tennessee
United States	Ironwood Investigational Site	Chesterfield	Michigan
United States	Ironwood Investigational Site	Chevy Chase	Maryland
United States	Ironwood Investigational Site	Christiansburg	Virginia
United States	Ironwood Investigational Site	Chula Vista	California
United States	Ironwood Investigational Site	Cincinnati	Ohio
United States	Ironwood Investigational Site	Cincinnati	Ohio
United States	Ironwood Investigational Site	Colorado Springs	Colorado
United States	Ironwood Investigational Site	Columbus	Ohio
United States	Ironwood Investigational Site	Concord	North Carolina
United States	Ironwood Investigational Site	Coral Gables	Florida
United States	Ironwood Investigational Site	Dakota Dunes	South Dakota
United States	Ironwood Investigational Site	Dallas	Texas
United States	Ironwood Investigational Site	Davidson	North Carolina
United States	Ironwood Investigational Site	DeLand	Florida
United States	Ironwood Investigational Site	El Paso	Texas
United States	Ironwood Investigational Site	Endwell	New York
United States	Ironwood Investigational Site	Evansville	Indiana
United States	Ironwood Investigational Site	Fargo	North Dakota
United States	Ironwood Investigational Site	Fayetteville	North Carolina
United States	Ironwood Investigational Site	Florissant	Missouri
United States	Ironwood Investigational Site	Garden Grove	California
United States	Ironwood Investigational Site	Great Neck	New York
United States	Ironwood Investigational Site	Greensboro	North Carolina
United States	Ironwood Investigational Site	Greer	South Carolina
United States	Ironwood Investigational Site	Hagerstown	Maryland
United States	Ironwood Investigational Site	Hialeah	Florida
United States	Ironwood Investigational Site	High Point	North Carolina
United States	Ironwood Investigational Site	Hollywood	Maryland
United States	Ironwood Investigational Site	Houston	Texas
United States	Ironwood Investigational Site	Houston	Texas
United States	Ironwood Investigational Site	Huntsville	Alabama
United States	Ironwood Investigational Site	Inverness	Florida
United States	Ironwood Investigational Site	Jackson	Mississippi
United States	Ironwood Investigational Site	Jupiter	Florida
United States	Ironwood Investigational Site	Kissimmee	Florida
United States	Ironwood Investigational Site	Knoxville	Tennessee
United States	Ironwood Investigational Site	La Crosse	Wisconsin
United States	Ironwood Investigational Site	La Mesa	California
United States	Ironwood Investigational Site	Las Vegas	Nevada
United States	Ironwood Investigational Site	Las Vegas	Nevada
United States	Ironwood Investigational Site	Lauderdale Lakes	Florida
United States	Ironwood Investigational Site	Levittown	Pennsylvania
United States	Ironwood Investigational Site	Logan	Utah
United States	Ironwood Investigational Site	Longview	Texas
United States	Ironwood Investigational Site	Lynchburg	Virginia
United States	Ironwood Investigational Site	Mentor	Ohio
United States	Ironwood Investigational Site	Metairie	Louisiana
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Nashville	Tennessee
United States	Ironwood Investigational Site	Newport Beach	California
United States	Ironwood Investigational Site	North Hollywood	California
United States	Ironwood Investigational Site	North Little Rock	Arkansas
United States	Ironwood Investigational Site	Oakwood	Georgia
United States	Ironwood Investigational Site	Oklahoma City	Oklahoma
United States	Ironwood Investigational Site	Orange	California
United States	Ironwood Investigational Site	Orlando	Florida
United States	Ironwood Investigational Site	Ormond Beach	Florida
United States	Ironwood Investigational Site	Phoenix	Arizona
United States	Ironwood Investigational Site	Plymouth	Minnesota
United States	Ironwood Investigational Site	Raleigh	North Carolina
United States	Ironwood Investigational Site	Saint Louis	Missouri
United States	Ironwood Investigational Site	San Antonio	Texas
United States	Ironwood Investigational Site	San Antonio	Texas
United States	Ironwood Investigational Site	San Antonio	Texas
United States	Ironwood Investigational Site	San Diego	California
United States	Ironwood Investigational Site	Sandy Springs	Georgia
United States	Ironwood Investigational Site	Shreveport	Louisiana
United States	Ironwood Investigational Site	Simpsonville	South Carolina
United States	Ironwood Investigational Site	South Miami	Florida
United States	Ironwood Investigational Site	South Ogden	Utah
United States	Ironwood Investigational Site	Sylvania	Ohio
United States	Ironwood Investigational Site	Tampa	Florida
United States	Ironwood Investigational Site	Thousand Oaks	California
United States	Ironwood Investigational Site	Traverse City	Michigan
United States	Ironwood Investigational Site	Troy	Michigan
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Washington	Pennsylvania
United States	Ironwood Investigational Site	Watertown	Massachusetts
United States	Ironwood Investigational Site	West Palm Beach	Florida
United States	Ironwood Investigational Site	Wilmington	North Carolina
United States	Ironwood Investigational Site	Winston Salem	North Carolina
United States	Ironwood Investigational Site	Winter Park	Florida
United States	Ironwood Investigational Site	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Spontaneous Bowel Movement (CSBM) Overall Responder	A 12-week CSBM Overall Responder is a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that is 3 or greater and increased by 1 or more from baseline. A CSBM is defined as a spontaneous bowel movement (SBM) that is associated with a sense of complete evacuation.; An SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.	Change from Baseline to Week 12	No