An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Chronic Constipation Clinical Trial

Official title:

An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765999
• Other study ID #: LIN-MD-02
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2008
• Est. completion date: January 31, 2012

Study information

• Verified date: January 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1559
• Est. completion date: January 31, 2012
• Est. primary completion date: January 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

Drug:
• Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).	Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.