A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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
1 other identifier
interventional
614
1 country
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
Shorter than P25 for phase_3
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2019
CompletedResults Posted
Study results publicly available
November 16, 2020
CompletedDecember 1, 2020
November 1, 2020
9 months
June 18, 2018
October 19, 2020
November 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score
Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Percentage of 6/12 Week Abdominal Score Responders (Responder Rate)
Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)
Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period
Baseline (14 days before randomization up to the time of randomization), Weeks 1-12
Study Arms (2)
Linaclotide 290 µg
EXPERIMENTALParticipants receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are rerandomized to receive either linaclotide 290 µg or placebo for 4 weeks in the Randomized Withdrawal Period.
Placebo
PLACEBO COMPARATORParticipants receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Hormonal contraception
- Double-barrier birth control
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ironwood Pharmaceuticals, Inc.lead
- Allergan Sales, LLCcollaborator
Study Sites (79)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
GW Research, Inc.
Chula Vista, California, 91910, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Diagnamics, Inc.
Encinitas, California, 92024, United States
MD Studies, Inc.
Fountain Valley, California, 92708, United States
Paragon Rx Clinical, Inc. - Garden Grove
Garden Grove, California, 92840, United States
Grossmont Center For Clinical Research
La Mesa, California, 91942, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Precision Research Institute
San Diego, California, 92114, United States
Paragon Rx Clinical, Inc.- Santa Ana
Santa Ana, California, 92703, United States
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
St. Joseph Heritage Healthcare
Yorba Linda, California, 92886, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Palmetto Research, LLC
Hialeah, Florida, 33016, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
The Chappel Group Research
Kissimmee, Florida, 34741, United States
Jesscan Medical Research
Miami, Florida, 33134, United States
Well Pharma Medical Research Corporation
Miami, Florida, 33143, United States
New Horizon Research Center
Miami, Florida, 33175, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Meridien Research - Tampa
Tampa, Florida, 33634, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Research Institute of Central Florida, LLC
Winter Park, Florida, 32792, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Alan A. Rosen, MD, PA
Baltimore, Maryland, 21215, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, 21742, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02131, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Gastroenterology Associates of West Michigan
Wyoming, Michigan, 49519, United States
Gastrointestinal Associates PA
Flowood, Mississippi, 39232, United States
St. Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59718, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Healthwise Medical Associates
Brooklyn, New York, 11206, United States
Long Island Gastrointestinal Research Group, LLP
Great Neck, New York, 11023, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28210, United States
Carolina Digestive Health Associates
Concord, North Carolina, 28025, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Peters Medical Research, LLC
High Point, North Carolina, 27262, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Clinical Trials of America - North Carolina, LLC
Winston-Salem, North Carolina, 27103, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Remington Davis, Inc.
Columbus, Ohio, 43215, United States
Dayton Gastroenterology, Inc.
Dayton, Ohio, 45415, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Partners In Clinical Research
Cumberland, Rhode Island, 02864, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
MW Clinical Research Center
Beaumont, Texas, 77701, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Southwest Clinical Trials
Houston, Texas, 77081, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Related Publications (2)
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.
PMID: 36227782DERIVEDChang 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.
PMID: 34465695DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Vanessa Chong
- Organization
- Ironwood Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Wilmin Bartolini, PhD
Ironwood Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
June 29, 2018
Study Start
June 20, 2018
Primary Completion
March 13, 2019
Study Completion
April 10, 2019
Last Updated
December 1, 2020
Results First Posted
November 16, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share