Clinical trial NCT03573908: A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allergan Sales, LLC
First posted: 2018-06-29
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period
timeFrame: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Secondary outcomes:
measure: Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score
timeFrame: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
measure: Percentage of 6/12 Week Abdominal Score Responders (Responder Rate)
timeFrame: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
measure: Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period
timeFrame: Baseline (14 days before randomization up to the time of randomization), Weeks 1-12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Fountain Valley
country: United States
facility: MD Studies, Inc.
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical, Inc. - Garden Grove
state: California
city: La Mesa
country: United States
facility: Grossmont Center For Clinical Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Santa Ana
country: United States
facility: Paragon Rx Clinical, Inc.- Santa Ana
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Yorba Linda
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Palmetto Research, LLC
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: The Chappel Group Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Jesscan Medical Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: Research Institute of Central Florida, LLC
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Alan A. Rosen, MD, PA
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center For Clinical Research
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Wyoming
country: United States
facility: Gastroenterology Associates of West Michigan
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates PA
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Center For Clinical Research
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Brooklyn
country: United States
facility: Healthwise Medical Associates
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group, LLP
state: New York
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Concord
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America - North Carolina, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Remington Davis, Inc.
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Cumberland
country: United States
facility: Partners In Clinical Research
state: Rhode Island
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Beaumont
country: United States
facility: MW Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Wilmin Bartolini, PhD
role: STUDY_CHAIR
References:
citation: Brenner DM, Lacy BE, Ford AC, Bartolini W, Wu J, Shea EP, Bochenek W, Boinpally R, Almansa C. Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials. Am J Gastroenterol. 2023 May 1;118(5):872-879. doi: 10.14309/ajg.0000000000002064. Epub 2022 Oct 12.
citation: Chang L, Lacy BE, Moshiree B, Kassebaum A, Abel JL, Hanlon J, Bartolini W, Boinpally R, Bochenek W, Fox SM, Mallick M, Tripp K, Omniewski N, Shea E, Borgstein N. Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System. Am J Gastroenterol. 2021 Sep 1;116(9):1929-1937. doi: 10.14309/ajg.0000000000001334.