Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
1 other identifier
interventional
310
1 country
60
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
60 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
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 18, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
March 5, 2013
CompletedMarch 5, 2013
January 1, 2013
1.1 years
November 18, 2006
September 28, 2012
January 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.
Change from Baseline to Week 4
Secondary Outcomes (5)
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Change from Baseline to Week 4
CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Change from Baseline to Week 4
Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period
Change from Baseline to Week 4
Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period
Change from Baseline to Week 4
Change From Baseline in Straining Score for the Treatment Period
Change from Baseline to Week 4
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:
- Patient is 18 years of age or older
- Patient meets colonoscopy requirements according to the American Gastroenterological Association
- Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
- Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
- Patient is fluent in English
You may not qualify if:
- Patient reports loose or watery stools
- Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
- Patient may not take prohibited medications per protocol
- Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Microbia Investigational Site
Huntsville, Alabama, 35801, United States
Microbia Investigational Site
Tucson, Arizona, 85715, United States
Microbia Investigational Site
Sherwood, Arkansas, 72120, United States
Microbia Investigational Site
Anaheim, California, United States
Microbia Investigational Site
Sacramento, California, United States
Microbia Investigational Site
San Diego, California, United States
Microbia Investigational Site
Boulder, Colorado, United States
Microbia Investigational Site
Bristol, Connecticut, 06011, United States
Microbia Investigational Site
Boynton Beach, Florida, United States
Microbia Investigational Site
Port Orange, Florida, United States
Microbia Investigational Site
Tampa, Florida, United States
Microbia Investigational Site
Stockbridge, Georgia, 30281, United States
Microbia Investigational Site
Peoria, Illinois, 61602, United States
Microbia Investigational Site
Indianapolis, Indiana, 46237, United States
Microbia Investigational Site
Clive, Iowa, United States
Microbia Investigational Site
Davenport, Iowa, United States
Microbia Investigational Site
Louisville, Kentucky, United States
Microbia Investigational Site
Monroe, Louisiana, 71201, United States
Microbia Investigational Site
Silver Spring, Maryland, 20901, United States
Microbia Investigational Site
Boston, Massachusetts, United States
Microbia Investigational Site
Ann Arbor, Michigan, United States
Microbia Investigational Site
Traverse City, Michigan, 49684, United States
Microbia Investigational Site
Olive Branch, Mississippi, United States
Microbia Investigational Site
Lincoln, Nebraska, United States
Microbia Investigational Site
Great Neck, New York, United States
Microbia Investigational Site
Pittsford, New York, United States
Microbia Investigational Site
Asheville, North Carolina, 28801, United States
Microbia Investigational Site
Chapel Hill, North Carolina, 9199668328, United States
Microbia Investigational Site
Charlotte, North Carolina, 28075, United States
Microbia Investigational Site
Fayetteville, North Carolina, United States
Microbia Investigational Site
Greensboro, North Carolina, United States
Microbia Investigational Site
Raleigh, North Carolina, 27612, United States
Microbia Investigational Site
Winston-Salem, North Carolina, 27103, United States
Microbia Investigational Site
Cincinnati, Ohio, United States
Microbia Investigational Site
Dayton, Ohio, 45440, United States
Microbia Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Microbia Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Microbia Investigational Site
Oklahoma City, Oklahoma, 73116, United States
Microbia Investigational Site
Tulsa, Oklahoma, 74104, United States
Microbia Investigational Site
Pittsburgh, Pennsylvania, United States
Microbia Investigational Site
Sellersville, Pennsylvania, United States
Microbia Investigational Site
Anderson, South Carolina, United States
Microbia Investigational Site
Columbia, South Carolina, United States
Microbia Investigational Site
Simpsonville, South Carolina, United States
Microbia Investigational Site
Summerville, South Carolina, 29485, United States
Microbia Investigational Site
Bristol, Tennessee, United States
Microbia Investigational Site
Chattanooga, Tennessee, United States
Microbia Investigational Site
Germantown, Tennessee, United States
Microbia Investigational Site
Jackson, Tennessee, 38301, United States
Microbia Investigational Site
Austin, Texas, 78745, United States
Microbia Investigational Site
Corsicana, Texas, 75110, 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, 23320, United States
Microbia Investigational Site
Lynchburg, Virginia, 24502, United States
Microbia Investigational Site
Olympia, Washington, United States
Microbia Investigational Site
Spokane, Washington, United States
Microbia Investigational Site
La Crosse, Wisconsin, 54601, United States
Microbia Investigational Site
Madison, Wisconsin, United States
Related Publications (1)
Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.
PMID: 20045700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Doug Levine, MD
- Organization
- Ironwood Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Microbia Medical Affairs
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
November 18, 2006
First Posted
November 22, 2006
Study Start
November 1, 2006
Primary Completion
December 1, 2007
Study Completion
February 1, 2008
Last Updated
March 5, 2013
Results First Posted
March 5, 2013
Record last verified: 2013-01