Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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
1 other identifier
interventional
420
2 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
85 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
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 13, 2007
CompletedFirst Posted
Study publicly available on registry
April 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
January 30, 2013
CompletedFebruary 4, 2013
January 1, 2013
10 months
April 13, 2007
September 28, 2012
January 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.
Change from Baseline to Week 12
Secondary Outcomes (6)
CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Change from Baseline to Week 12
Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period
Change from Baseline to Week 12
Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period
Change from Baseline to Week 12
Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period
Change from Baseline to Week 12
Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period
Change from Baseline to Week 12
- +1 more secondary outcomes
Study Arms (5)
72 ug linaclotide acetate
ACTIVE COMPARATOR145 ug linaclotide acetate
ACTIVE COMPARATOR290 ug linaclotide acetate
ACTIVE COMPARATOR579 ug linaclotide acetate
ACTIVE COMPARATORMatching Placebo
PLACEBO COMPARATORInterventions
Oral, once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Microbia Investigational Site
Huntsville, Alabama, 35801, United States
Microbia Investigational Site
Chandler, Arizona, United States
Microbia Investigational Site
Tuscon, Arizona, United States
Microbia Investigational Site
Sherwood, Arkansas, United States
Microbia Investigational Site
Anaheim, California, United States
Microbia Investigational Site
Garden Grove, California, United States
Microbia Investigational Site
Sacramento, California, United States
Microbia Investigational Site
San Diego, California, United States
Microbia Investigational Site
Bristol, Connecticut, United States
Microbia Investigational Site
Boynton Beach, Florida, United States
Microbia Investigational Site
Dunedin, Florida, United States
Microbia Investigational Site
Largo, Florida, United States
Microbia Investigational Site
Ocala, Florida, United States
Microbia Investigational Site
Port Orange, Florida, United States
Microbia Investigational Site
Stuart, Florida, United States
Microbia Investigational Site
Tampa, Florida, 33607, United States
Microbia Investigational Site
Stockbridge, Georgia, United States
Microbia Investigational Site
Libertyville, Illinois, United States
Microbia Investigational Site
Peoria, Illinois, 60601, United States
Microbia Investigational Site
Clive, Iowa, United States
Microbia Investigational Site
Davenport, Iowa, United States
Microbia Investigational Site
Mission, Kansas, United States
Microbia Investigational Site
Shawnee, Kansas, United States
Microbia Investigational Site
Baton Rouge, Louisiana, United States
Microbia Investigational Site
Monroe, Louisiana, 71201, United States
Microbia Investigational Site
West Monroe, Louisiana, United States
Microbia Investigational Site
Annapolis, Maryland, United States
Microbia Investigational Site
Silver Spring, Maryland, United States
Microbia Investigational Site
Fall River, Massachusetts, United States
Microbia Investigational Site
Ann Arbor, Michigan, United States
Microbia Investigational Site
St Louis, Missouri, United States
Microbia Investigational Site
Missoula, Montana, United States
Microbia Investigational Site
Henderson, Nevada, United States
Microbia Investigational Site
Las Vegas, Nevada, United States
Microbia Investigational Site
Blackwood, New Jersey, United States
Microbia Investigational Site
Great Neck, New York, 11020, United States
Microbia Investigational Site
Pittsford, New York, United States
Microbia Investigational Site
Asheville, North Carolina, United States
Microbia Investigational Site
Chapel Hill, North Carolina, United States
Microbia Investigational Site
Elkin, North Carolina, United States
Microbia Investigational Site
Greensboro, North Carolina, United States
Microbia Investigational Site
Harrisburg, North Carolina, United States
Microbia Investigational Site
Hickory, North Carolina, United States
Microbia Investigational Site
Raleigh, North Carolina, United States
Microbia Investigational Site
Statesville, North Carolina, United States
Microbia Investigational Site
Winston-Salem, North Carolina, United States
Microbia Investigational Site
Cincinnati, Ohio, United States
Microbia Investigational Site
Cleveland, Ohio, United States
Microbia Investigational Site
Dayton, Ohio, United States
Microbia Investigational Site
Sylvania, Ohio, United States
Microbia Investigational Site
Oklahoma City, Oklahoma, United States
Microbia Investigational Site
Tulsa, Oklahoma, United States
Microbia Investigational Site
Yukon, Oklahoma, United States
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Medford, Oregon, United States
Microbia Investigational Site
Levittown, Pennsylvania, United States
Microbia Investigational Site
Pittsburgh, Pennsylvania, United States
Microbia Investigational Site
Reading, Pennsylvania, United States
Microbia Investigational Site
Sellersville, Pennsylvania, 18960, United States
Microbia Investigational Site
Anderson, South Carolina, United States
Microbia Investigational Site
Mt. Pleasant, South Carolina, United States
Microbia Investigational Site
Simpsonville, South Carolina, United States
Microbia Investigational Site
Summerville, South Carolina, United States
Microbia Investigational Site
Bristol, Tennessee, United States
Microbia Investigational Site
Germantown, Tennessee, United States
Microbia Investigational Site
Jackson, Tennessee, United States
Microbia Investigational Site
Kingsport, Tennessee, United States
Microbia Investigational Site
Beaumont, Texas, United States
Microbia Investigational Site
Corsicana, Texas, United States
Microbia Investigational Site
El Paso, Texas, United States
Microbia Investigational Site
San Antonio, Texas, United States
Microbia Investigational Site
Ogden, Utah, United States
Microbia Investigational Site
Chesapeake, Virginia, United States
Microbia Investigational Site
Lynchburg, Virginia, United States
Microbia Investigational Site
Richmond, Virginia, United States
Microbia Investigational Site
Lakewood, Washington, United States
Microbia Investigational Site
Olympia, Washington, United States
Microbia Investigational Site
Vancouver, Washington, United States
Microbia Investigational Site
Charleston, West Virginia, United States
Microbia Investigational Site
La Crosse, Wisconsin, United States
Microbia Investigational Site
Abbortsford, British Columbia, Canada
Microbia Investigational Site
Winnipeg, Manitoba, Canada
Microbia Investigational Site
Guelph, Ontario, Canada
Microbia Investigational Site
Milton, Ontario, Canada
Microbia Investigational Site
Toronto, Ontario, Canada
Microbia Investigational Site
Saskatoon, Saskatchewan, Canada
Related Publications (2)
Lembo A, Kuo B, Boinpally R, Li E, Mallick M, Bochenek W, Bartolini W. Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Jan;57(2):192-204. doi: 10.1111/apt.17274. Epub 2022 Nov 2.
PMID: 36324245DERIVEDJohnston 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.
PMID: 20801122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Doug Levine, MD
- Organization
- Ironwood Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Microbia Medical Director, MD
Microbia, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2007
First Posted
April 16, 2007
Study Start
April 1, 2007
Primary Completion
February 1, 2008
Study Completion
April 1, 2008
Last Updated
February 4, 2013
Results First Posted
January 30, 2013
Record last verified: 2013-01