Irritable Bowel Syndrome Characterized by Constipation Clinical Trial
Official title:
A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
Verified date | November 2020 |
Source | Ironwood Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ironwood Pharmaceuticals, Inc. | Allergan Sales, LLC |
United States,
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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