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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03573908
Other study ID # MCP-103-312
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 20, 2018
Est. completion date April 10, 2019

Study information

Verified date November 2020
Source Ironwood Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.


Recruitment information / eligibility

Status Completed
Enrollment 614
Est. completion date April 10, 2019
Est. primary completion date March 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. Hormonal contraception 2. Double-barrier birth control 3. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Linaclotide
Oral capsule
Placebo
Matching placebo oral capsule

Locations

Country Name City State
United States Alan A. Rosen, MD, PA Baltimore Maryland
United States MW Clinical Research Center Beaumont Texas
United States Boston Clinical Trials, Inc. Boston Massachusetts
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Connecticut Clinical Research Institute Bristol Connecticut
United States Healthwise Medical Associates Brooklyn New York
United States Carolina Digestive Health Associates Charlotte North Carolina
United States ClinSearch, LLC Chattanooga Tennessee
United States New River Valley Research Institute Christiansburg Virginia
United States GW Research, Inc. Chula Vista California
United States Hightop Medical Research Center Cincinnati Ohio
United States New Horizons Clinical Research Cincinnati Ohio
United States Remington Davis, Inc. Columbus Ohio
United States Carolina Digestive Health Associates Concord North Carolina
United States Clinical Research of South Florida Coral Gables Florida
United States Kindred Medical Institute for Clinical Trials, LLC Corona California
United States Partners In Clinical Research Cumberland Rhode Island
United States Meridian Clinical Research Dakota Dunes South Dakota
United States Dayton Gastroenterology, Inc. Dayton Ohio
United States Hometown Urgent Care and Research Dayton Ohio
United States Avail Clinical Research, LLC DeLand Florida
United States Diagnamics, Inc. Encinitas California
United States Lillestol Research Fargo North Dakota
United States Cumberland Research Associates Fayetteville North Carolina
United States Gastrointestinal Associates PA Flowood Mississippi
United States MD Studies, Inc. Fountain Valley California
United States Paragon Rx Clinical, Inc. - Garden Grove Garden Grove California
United States Long Island Gastrointestinal Research Group, LLP Great Neck New York
United States Mountain View Clinical Research, Inc. Greer South Carolina
United States Meritus Center For Clinical Research Hagerstown Maryland
United States Palmetto Research, LLC Hialeah Florida
United States Peters Medical Research, LLC High Point North Carolina
United States Southwest Clinical Trials Houston Texas
United States Southwest Clinical Trials Houston Texas
United States Clinical Research Associates Huntsville Alabama
United States Nature Coast Clinical Research, LLC Inverness Florida
United States The Chappel Group Research Kissimmee Florida
United States New Phase Research & Development Knoxville Tennessee
United States Grossmont Center For Clinical Research La Mesa California
United States Clinical Research of South Nevada Las Vegas Nevada
United States Blue Ridge Medical Research Lynchburg Virginia
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Clinical Trials Management, LLC Metairie Louisiana
United States Jesscan Medical Research Miami Florida
United States New Horizon Research Center Miami Florida
United States Well Pharma Medical Research Corporation Miami Florida
United States San Marcus Research Clinic, Inc. Miami Lakes Florida
United States Ocean Blue Medical Research Center, Inc. Miami Springs Florida
United States Facey Medical Foundation Mission Hills California
United States Delta Research Partners, LLC Monroe Louisiana
United States Providence Clinical Research North Hollywood California
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Advanced Research Institute Ogden Utah
United States IPS Research Company Oklahoma City Oklahoma
United States Ormond Medical Arts Pharmaceutical Research Center Ormond Beach Florida
United States Elite Clinical Studies Phoenix Arizona
United States Wake Research Associates, LLC Raleigh North Carolina
United States St. Louis Center For Clinical Research Saint Louis Missouri
United States Diagnostics Research Group San Antonio Texas
United States Quality Research, Inc. San Antonio Texas
United States Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas
United States Precision Research Institute San Diego California
United States Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States Paragon Rx Clinical, Inc.- Santa Ana Santa Ana California
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Precision Clinical Research Sunrise Florida
United States Meridien Research - Tampa Tampa Florida
United States Millennium Clinical Trials Thousand Oaks California
United States Adobe Clinical Research, LLC Tucson Arizona
United States Chase Medical Research, LLC Waterbury Connecticut
United States MedVadis Research Corporation Watertown Massachusetts
United States Palm Beach Research Center West Palm Beach Florida
United States PMG Research of Wilmington Wilmington North Carolina
United States Clinical Trials of America - North Carolina, LLC Winston-Salem North Carolina
United States Lyndhurst Clinical Research Winston-Salem North Carolina
United States PMG Research of Winston-Salem Winston-Salem North Carolina
United States Research Institute of Central Florida, LLC Winter Park Florida
United States Gastroenterology Associates of West Michigan Wyoming Michigan
United States St. Joseph Heritage Healthcare Yorba Linda California

Sponsors (2)

Lead Sponsor Collaborator
Ironwood Pharmaceuticals, Inc. Allergan Sales, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period and used as the dependent variable in the mixed model with repeated measures (MMRM) model. MMRM results are based on a model with treatment, analysis week, region and treatment-by-week interaction as fixed effects and baseline as a covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Secondary Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The 12-week abdominal score was the average of the non-missing abdominal scores reported over the course of the treatment period. Change from baseline (BL) was calculated as the 12-week score minus the baseline score. The table presents the percentage of participants whose 12-week change from baseline was less than or equal to the threshold value of the score change (cumulative distribution of change). Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Secondary Percentage of 6/12 Week Abdominal Score Responders (Responder Rate) A 6/12 week abdominal score responder is a participant who meets the weekly abdominal score responder criteria for at least 6 out of the 12 weeks of the Treatment Period. For each week in the Treatment Period, a weekly abdominal score responder is a participant who has an improvement from baseline of at least 2 points (ie, a -2 point change from baseline) in the respective weekly abdominal score. If a participant did not have at least 4 completed eDiary entries for a particular Treatment Period week, the participant was not considered a responder for that week.
A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period.
Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Secondary Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period and used as the dependent variable in the mixed model with repeated measures (MMRM) model. MMRM results are based on a model with treatment, analysis week, region and treatment-by-week interaction as fixed effects and baseline as a covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline (14 days before randomization up to the time of randomization), Weeks 1-12
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