Clinical trial NCT00765882: Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Keywords: Constipation
Chronic Constipation
Linaclotide
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Ironwood Pharmaceuticals, Inc.
First posted: 2008-10-03
Enrollment: 633
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 objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder


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 CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient demonstrates continued chronic constipation 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 Irritable Bowel Syndrome (IBS)
* 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: Complete Spontaneous Bowel Movement (CSBM) Overall Responder
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
timeFrame: Change from Baseline to Week 12
measure: 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
timeFrame: Change from Baseline to Week 12
measure: 12-Week Stool Consistency
timeFrame: Change from Baseline to Week 12
measure: 12-Week Severity of Straining
timeFrame: Change from Baseline to Week 12
measure: 12-Week Abdominal Discomfort
timeFrame: Change from Baseline to Week 12
measure: 12-Week Bloating
timeFrame: Change from Baseline to Week 12
measure: 12-Week Constipation Severity
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Huntsville
country: United States
facility: Forest Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Forest Investigative Site
state: Arizona
city: Mesa
country: United States
facility: Forest Investigative Site
state: Arizona
city: Peoria
country: United States
facility: Forest Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Forest Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site
state: Arizona
city: Burbank
country: United States
facility: Forest Investigative Site
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site
state: California
city: Foothill Ranch
country: United States
facility: Forest Investigative Site
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
city: Orange
country: United States
facility: Forest Investigative Site
state: California
city: Westlake Village
country: United States
facility: Forest Investigative Site
state: California
city: Boulder
country: United States
facility: Forest Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Forest Investigative Site
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Sites
state: Colorado
city: Longmont
country: United States
facility: Forest Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site
state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Boca Raton
country: United States
facility: Forest Investigative Site
state: Florida
city: Bradenton
country: United States
facility: Forest Investigative Site
state: Florida
city: Brooksville
country: United States
facility: Forest Investigative Site
state: Florida
city: Ft. Myers
country: United States
facility: Forest Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Forest Investigative Site
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: Panama City
country: United States
facility: Forest Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: Trinity
country: United States
facility: Forest Investigative Site
state: Florida
city: Zephyrhills
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Stockbridge
country: United States
facility: Forest Investigative Site
state: Georgia
city: Woodstock
country: United States
facility: Forest Investigative Site
state: Georgia
city: Idaho Falls
country: United States
facility: Forest Investigative Site
state: Idaho
city: Rockford
country: United States
facility: Forest Investigative Site
state: Illinois
city: Elkhart
country: United States
facility: Forest Investigative Site
state: Indiana
city: Evansville
country: United States
facility: Forest Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site
state: Indiana
city: Iowa City
country: United States
facility: Forest Investigative Site
state: Iowa
city: Arkansas City
country: United States
facility: Forest Investigative Site
state: Kansas
city: Newton
country: United States
facility: Forest Investigative Site
state: Kansas
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Madisonville
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Chevy Chase
country: United States
facility: Forest Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: Forest Investigative Site
state: Maryland
city: Lutherville
country: United States
facility: Forest Investigative Site
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Chaska
country: United States
facility: Forest Investigative Site
state: Minnesota
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: Vineland
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site
state: New Mexico
city: Brooklyn
country: United States
facility: Forest Investigative Site
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site
state: New York
city: Fayetteville
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Bismark
country: United States
facility: Forest Investigative Site
state: North Dakota
city: Akron
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Forest Investigative Site
state: Oklahoma
city: Bensalem
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Forest Investigative Site
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site
state: Virginia
city: Christianburg
country: United States
facility: Forest Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Forest Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site
state: Washington
city: Lakewood
country: United States
facility: Forest Investigative Site
state: Washington
city: Wenatchee
country: United States
facility: Forest Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: Forest Investigative Site
state: Wisconsin
city: Vancouver
country: Canada
facility: Forest Investigative Site
state: British Columbia
city: Hamilton
country: Canada
facility: Forest Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Forest Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Forest Investigative Site
state: Ontario
city: Sarnia
country: Canada
facility: Forest Investigative Site 1
state: Ontario
city: Sarnia
country: Canada
facility: Forest Investigative Site 2
state: Ontario
city: Sudbury
country: Canada
facility: Forest Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site
state: Ontario
Study officials:
affiliation: Forest Laboratories
name: Paul F.C. Eng, PhD
role: STUDY_DIRECTOR
References:
citation: Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
citation: Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.