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

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559206
• Other study ID #: MCP-103-204
• Status: Completed
• Phase: Phase 2
• Start date: October 22, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: April 2020
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has completed a colonoscopy 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 diagnosis of IBS-C

• Patient demonstrates continued IBS-C 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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

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	Arlington	Texas
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	Bozeman	Montana
United States	Ironwood Investigational Site	Bristol	Tennessee
United States	Ironwood Investigational Site	Bristol	Connecticut
United States	Ironwood Investigational Site	Brooklyn	New York
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	Concord	North Carolina
United States	Ironwood Investigational Site	Dakota Dunes	South Dakota
United States	Ironwood Investigational Site	Davidson	North Carolina
United States	Ironwood Investigational Site	El Paso	Texas
United States	Ironwood Investigational Site	Evansville	Indiana
United States	Ironwood Investigational Site	Fayetteville	North Carolina
United States	Ironwood Investigational Site	Garden Grove	California
United States	Ironwood Investigational Site	Hialeah	Florida
United States	Ironwood Investigational Site	Houston	Texas
United States	Ironwood Investigational Site	Huntsville	Alabama
United States	Ironwood Investigational Site	Jackson	Mississippi
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	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	Newport Beach	California
United States	Ironwood Investigational Site	North Little Rock	Arkansas
United States	Ironwood Investigational Site	Oakwood	Georgia
United States	Ironwood Investigational Site	Ogden	Utah
United States	Ironwood Investigational Site	Orange	California
United States	Ironwood Investigational Site	Orlando	Florida
United States	Ironwood Investigational Site	Phoenix	Arizona
United States	Ironwood Investigational Site	Pittsburgh	Pennsylvania
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	Utah
United States	Ironwood Investigational Site	Sandy Springs	Georgia
United States	Ironwood Investigational Site	Shreveport	Louisiana
United States	Ironwood Investigational Site	South Miami	Florida
United States	Ironwood Investigational Site	Tampa	Florida
United States	Ironwood Investigational Site	Thousand Oaks	California
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Waterbury	Connecticut
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	Wyoming	Michigan
United States	Ironwood Investigational Site	Xenia	Ohio

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	Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo	Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.	Baseline, up to Week 12
Primary	Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo	Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.	Baseline, up to Week 12
Primary	Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo	A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.	Baseline, up to Week 12
Primary	Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo	A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.	Baseline, up to Week 12
Primary	Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo	A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.; Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.; Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of =30% in the mean daily worst abdominal pain scores for that week.; Weekly CSBM +1 Responder: A participant who has an increase from baseline of =1 in the CSBM weekly rate for that week.; A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.	up to Week 12
Primary	Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo	A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.; Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.; Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of =30% in the mean daily worst abdominal pain scores for that week.; Weekly CSBM +1 Responder: A participant who has an increase from baseline of =1 in the CSBM weekly rate for that week.; A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.	up to Week 12