Clinical trial NCT00765999: An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Official title: An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Irritable Bowel Syndrome With Constipation
Keywords: Constipation
Chronic Constipation
Irritable Bowel Syndrome With Constipation
Linaclotide
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Ironwood Pharmaceuticals, Inc.
First posted: 2008-10-03
Enrollment: 1559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).


Eligibility criteria: Inclusion Criteria:

* Patients must have

  * entered study LIN-MD 01\[NCT00765882\] or LIN-MD-31 \[NCT00948818\] and at minimum completed the pre-treatment period or
  * completed one of the following studies: MCP-103-004 \[NCT00306748\], MCP-103-005 \[NCT00258193\], MCP-103-201 \[NCT00402337\], MCP-103-202 \[NCT00460811\]
* Sexually active patients of childbearing potential agree to use birth control
* Females of childbearing potential must have a negative urine pregnancy test prior to dosing
* Lactating females must agree not to breastfeed
* Patient must meet protocol criteria for CC or IBS-C

Exclusion Criteria:

* Patient must not use protocol-defined prohibited medicine
* Patient is planning to receive an investigational drug at any time during the study
* Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test

Primary outcomes:
measure: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Innovative Clinical Trials
state: Alabama
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Phoenix
country: United States
facility: Carl T Hayden VA Medical Center GI Section-CS-111G
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Encinitas
country: United States
facility: Encompass Clinical Research North Coast
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Orange
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Boulder
country: United States
facility: Boulder Medical Center, P.C.
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Denver
country: United States
facility: Colorado Gastroenterology, Prof LLC
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton, Inc.
state: Florida
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates Clinical Study Center
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research, Inc.
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: Ocala
country: United States
facility: RenStar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Panama City
country: United States
facility: Emerald Coast Research Associates
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A. Clinical Research Division
state: Florida
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark WomenCare Specialist
state: Idaho
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Arkansas City
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Madisonville
country: United States
facility: Trover Health System
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Development Centers, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Towson
country: United States
facility: Charm City Research
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Kalamazoo
country: United States
facility: Kalamazoo Gastroenterology Hepatology
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Research Two Twelve Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Vineland
country: United States
facility: The Gastroenterology Group of S.J.
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center
state: New Mexico
city: Brooklyn
country: United States
facility: Lifeline Research Institute
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Setauket
country: United States
facility: Gastrointestinal Research Associates, LLC
state: New York
city: Boone
country: United States
facility: MediSpect, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, P.A.
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, INC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Remington Davis
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Greer
country: United States
facility: Mountain View Clinical Research
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Dallas
country: United States
facility: Research Across America RHD Professional Plaza IV
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Clinic
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Salt Lake City
country: United States
facility: Fatigue Consultation Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Department of Gastroenterology University of Utah Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Department of Veterans Affairs Research Department
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Lakewood
country: United States
facility: Radiant Research, Inc.
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center Clinical Research Dept.
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc. Clinical Research Center
state: Wisconsin
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph Healthcare
state: Ontario
city: Newmarket
country: Canada
facility: MedPhase Canada
state: Ontario
city: Ottawa
country: Canada
facility: Meadowlands Family Health Center
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Center
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research, Inc.
state: Ontario
city: Toronto
country: Canada
facility: PrimeHealth Clinical Research
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
Study officials:
affiliation: Forest Laboratories
name: Paul Eng, PhD
role: STUDY_DIRECTOR
References: