Clinical trial NCT00402337: Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Constipation
Chronic Constipation
Microbia
linaclotide
linaclotide acetate
MD-1100
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 310
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 primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
timeFrame: Change from Baseline to Week 4
Secondary outcomes:
measure: SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
timeFrame: Change from Baseline to Week 4
measure: CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
timeFrame: Change from Baseline to Week 4
measure: Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period
timeFrame: Change from Baseline to Week 4
measure: Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period
timeFrame: Change from Baseline to Week 4
measure: Change From Baseline in Straining Score for the Treatment Period
timeFrame: Change from Baseline to Week 4
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Microbia Investigational Site
state: Alabama
city: Tucson
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: Sacramento
country: United States
facility: Microbia Investigational Site
state: California
city: San Diego
country: United States
facility: Microbia Investigational Site
state: California
city: Boulder
country: United States
facility: Microbia Investigational Site
state: Colorado
city: Bristol
country: United States
facility: Microbia Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Microbia Investigational Site
state: Florida
city: Port Orange
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: Peoria
country: United States
facility: Microbia Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Microbia Investigational Site
state: Indiana
city: Clive
country: United States
facility: Microbia Investigational Site
state: Iowa
city: Davenport
country: United States
facility: Microbia Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Microbia Investigational Site
state: Kentucky
city: Monroe
country: United States
facility: Microbia Investigational Site
state: Louisiana
city: Silver Spring
country: United States
facility: Microbia Investigational Site
state: Maryland
city: Boston
country: United States
facility: Microbia Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Microbia Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Microbia Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Microbia Investigational Site
state: Mississippi
city: Lincoln
country: United States
facility: Microbia Investigational Site
state: Nebraska
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: Charlotte
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Raleigh
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: Dayton
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Microbia Investigational Site
state: Oklahoma
city: Pittsburgh
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: Columbia
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: Chattanooga
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: Austin
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: Olympia
country: United States
facility: Microbia Investigational Site
state: Washington
city: Spokane
country: United States
facility: Microbia Investigational Site
state: Washington
city: La Crosse
country: United States
facility: Microbia Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: Microbia Investigational Site
state: Wisconsin
Study officials:
affiliation: Microbia, Inc.
name: Microbia Medical Affairs
role: STUDY_DIRECTOR
References:
citation: 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.