Clinical trial NCT00938717: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: IBS
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2009-07-14
Enrollment: 805
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: The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).


Eligibility criteria: Inclusion Criteria:

* Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
* Patient meets protocol criteria for diagnosis of IBS-C
* Patient demonstrates continued IBS-C through Pretreatment Period
* Patient is compliant with IVRS

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: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
timeFrame: Change from Baseline to Week 12
measure: Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
timeFrame: Change from Baseline to Week 12
measure: Abdominal Pain Responder, 9 Out of 12 Weeks
timeFrame: Change from Baseline to Week 12
measure: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency
timeFrame: Change from Baseline to Week 12
measure: 12-Week Spontaneous Bowl Movement (SBM) Frequency
timeFrame: Change from Baseline to Week 12
measure: 12-Week Change in Stool Consistency
timeFrame: Change from Baseline to Week 12
measure: 12-Week Change in Severity of Straining
timeFrame: Change from Baseline to Week 12
measure: 12-Week Change in Abdominal Pain Score
timeFrame: Change from Baseline to Week 12
measure: 12-Week Change in Abdominal Discomfort
timeFrame: Change from Baseline to Week 12
measure: 12-Week Change in Bloating
timeFrame: Change from Baseline to Week 12
measure: Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
timeFrame: Change from Baseline to Week 12
measure: Abdominal Pain Responder for 6 Out of 12 Weeks
timeFrame: Change from Baseline to Week 12
measure: 12-Week Percent of Abdominal Pain-free Days
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Sherwood
country: United States
facility: Ironwood Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Ironwood Investigational Site
state: California
city: Chula Vista
country: United States
facility: Ironwood Investigational Site
state: California
city: Encinitas
country: United States
facility: Ironwood Investigational Site
state: California
city: Garden Grove
country: United States
facility: Ironwood Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Ironwood Investigational Site
state: California
city: Orange
country: United States
facility: Ironwood Investigational Site
state: California
city: San Carlos
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Ironwood Investigational Site
state: Colorado
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Inverness
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Newnan
country: United States
facility: Ironwood Investigational Site
state: Georgia
city: Peoria
country: United States
facility: Ironwood Investigational Site
state: Illinois
city: Anderson
country: United States
facility: Ironwood Investigational Site
state: Indiana
city: Clive
country: United States
facility: Ironwood Investigational Site
state: Iowa
city: Davenport
country: United States
facility: Ironwood Investigational Site
state: Iowa
city: Mission
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Monroe
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Hollywood
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Laurel
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Chesterfield
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Troy
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: Ironwood Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Ironwood Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Ironwood Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Ironwood Investigational Site
state: Missouri
city: Marlton
country: United States
facility: Ironwood Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Ironwood Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: Ironwood Investigational Site
state: New York
city: Pittsford
country: United States
facility: Ironwood Investigational Site
state: New York
city: Asheboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Asheville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Harrisburg
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Ironwood Investigational Site
state: Oklahoma
city: Yukon
country: United States
facility: Ironwood Investigational Site
state: Oklahoma
city: Lancaster
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Levittown
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Washington
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Ironwood Investigational Site
state: Texas
city: El Paso
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Houston
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Irving
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Longview
country: United States
facility: Ironwood Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Sugarland
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Ogden
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Ironwood Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Ironwood Investigational Site
state: Washington
city: La Crosse
country: United States
facility: Ironwood Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Ironwood Investigational Site
state: Wisconsin
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Jeffrey M. Johnston, MD, FACP
role: STUDY_CHAIR
References:
citation: Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
citation: Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.