Clinical trial NCT00460811: Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: Irritable Bowel Syndrome with Constipation
IBS
Irritable Bowel Syndrome
linaclotide acetate
linaclotide
MD-1100
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 420
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, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.


Eligibility criteria: Inclusion Criteria:

* Must not be pregnant or breastfeeding and agree to use birth control;
* Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
* Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
* Demonstrates English fluency and has access to a touch-tone telephone.

Exclusion Criteria:

* Recent history of mushy or watery stools;
* Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
* Clinically-significant alarm symptoms;
* Secondary causes of constipation or evacuation disorders;
* Surgery to the gastrointestinal tract;
* Usage of prohibited medications.

Primary outcomes:
measure: Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
timeFrame: Change from Baseline to Week 12
measure: Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period
timeFrame: Change from Baseline to Week 12
measure: Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period
timeFrame: Change from Baseline to Week 12
measure: Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period
timeFrame: Change from Baseline to Week 12
measure: Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period
timeFrame: Change from Baseline to Week 12
measure: Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Microbia Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Microbia Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: Microbia Investigational Site
state: Arizona
city: Sherwood
country: United States
facility: Microbia Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Microbia Investigational Site
state: California
city: Garden Grove
country: United States
facility: Microbia Investigational Site
state: California
city: Sacramento
country: United States
facility: Microbia Investigational Site
state: California
city: San Diego
country: United States
facility: Microbia Investigational Site
state: California
city: Bristol
country: United States
facility: Microbia Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Microbia Investigational Site
state: Florida
city: Dunedin
country: United States
facility: Microbia Investigational Site
state: Florida
city: Largo
country: United States
facility: Microbia Investigational Site
state: Florida
city: Ocala
country: United States
facility: Microbia Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Microbia Investigational Site
state: Florida
city: Stuart
country: United States
facility: Microbia Investigational Site
state: Florida
city: Tampa
country: United States
facility: Microbia Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: Microbia Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Microbia Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Microbia Investigational Site
state: Illinois
city: Clive
country: United States
facility: Microbia Investigational Site
state: Iowa
city: Davenport
country: United States
facility: Microbia Investigational Site
state: Iowa
city: Mission
country: United States
facility: Microbia Investigational Site
state: Kansas
city: Shawnee
country: United States
facility: Microbia Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Microbia Investigational Site
state: Louisiana
city: Monroe
country: United States
facility: Microbia Investigational Site
state: Louisiana
city: West Monroe
country: United States
facility: Microbia Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Microbia Investigational Site
state: Maryland
city: Silver Spring
country: United States
facility: Microbia Investigational Site
state: Maryland
city: Fall River
country: United States
facility: Microbia Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Microbia Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: Microbia Investigational Site
state: Missouri
city: Missoula
country: United States
facility: Microbia Investigational Site
state: Montana
city: Henderson
country: United States
facility: Microbia Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Microbia Investigational Site
state: Nevada
city: Blackwood
country: United States
facility: Microbia Investigational Site
state: New Jersey
city: Great Neck
country: United States
facility: Microbia Investigational Site
state: New York
city: Pittsford
country: United States
facility: Microbia Investigational Site
state: New York
city: Asheville
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Elkin
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Harrisburg
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Yukon
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Microbia Investigational Site
state: Oregon
city: Levittown
country: United States
facility: Microbia Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Microbia Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Microbia Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Microbia Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Microbia Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Microbia Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Microbia Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: Microbia Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Microbia Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Microbia Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Microbia Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Microbia Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Microbia Investigational Site
state: Texas
city: Corsicana
country: United States
facility: Microbia Investigational Site
state: Texas
city: El Paso
country: United States
facility: Microbia Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Microbia Investigational Site
state: Texas
city: Ogden
country: United States
facility: Microbia Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Microbia Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: Microbia Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Microbia Investigational Site
state: Virginia
city: Lakewood
country: United States
facility: Microbia Investigational Site
state: Washington
city: Olympia
country: United States
facility: Microbia Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Microbia Investigational Site
state: Washington
city: Charleston
country: United States
facility: Microbia Investigational Site
state: West Virginia
city: LaCrosse
country: United States
facility: Microbia Investigational Site
state: Wisconsin
city: Abbortsford
country: Canada
facility: Microbia Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Microbia Investigational Site
state: Manitoba
city: Guelph
country: Canada
facility: Microbia Investigational Site
state: Ontario
city: Milton
country: Canada
facility: Microbia Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Microbia Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: Microbia Investigational Site
state: Saskatchewan
Study officials:
affiliation: Microbia, Inc.
name: Microbia Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. doi: 10.1053/j.gastro.2010.08.041. Epub 2010 Aug 27.