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

NCT00765999 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LIN-MD-02
• Study Type: interventional
• Target: 1,559
• Locations: 2 countries
• Sites: 118

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).

Conditions

Chronic Constipation; Irritable Bowel Syndrome With Constipation

Keywords

Constipation; Chronic Constipation; Irritable Bowel Syndrome With Constipation; Linaclotide

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Linaclotide

EXPERIMENTAL

Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Drug: Linaclotide

Interventions

Linaclotide DRUG

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

Also known as: Linzess

Linaclotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead
• Ironwood Pharmaceuticals, Inc.: collaborator

Study Sites (118)

Innovative Clinical Trials

Birmingham, Alabama, 35205, United States

Location

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Radiant Research, Inc.

Chandler, Arizona, 85224, United States

Location

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

Pivotal Research Center

Peoria, Arizona, 85381, United States

Location

Carl T Hayden VA Medical Center GI Section-CS-111G

Phoenix, Arizona, 85012, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Radiant Research, Inc.

Scottsdale, Arizona, 85251, United States

Location

Genova Clinical Research, Inc.

Tucson, Arizona, 85704, United States

Location

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Encompass Clinical Research North Coast

Encinitas, California, 92024, United States

Location

Family Medical Center

Foothill Ranch, California, 92610, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Advanced Clinical Research Institute

Orange, California, 92869, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Boulder Medical Center, P.C.

Boulder, Colorado, 80304, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80907, United States

Location

Colorado Gastroenterology, Prof LLC

Denver, Colorado, 80205, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Western States Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Clinical Trials Management of Boca Raton, Inc.

Boca Raton, Florida, 33428, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Clinical Physiology Associates Clinical Study Center

Fort Myers, Florida, 33916, United States

Location

Jupiter Research, Inc.

Jupiter, Florida, 33458, United States

Location

FPA Clinical Research

Kissimmee, Florida, 34741, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

RenStar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Emerald Coast Research Associates

Panama City, Florida, 32405, United States

Location

University Clinical Research, Inc.

Pembroke Pines, Florida, 33024, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Advanced Research Institute

Trinity, Florida, 34655, United States

Location

Florida Medical Clinic, P.A. Clinical Research Division

Zephyrhills, Florida, 33542, United States

Location

Radiant Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Atlanta Gastroenterology Associates, LLC

Marietta, Georgia, 30067, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Rosemark WomenCare Specialist

Idaho Falls, Idaho, 83404, United States

Location

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Heartland Research Associates, LLC

Arkansas City, Kansas, 67005, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Trover Health System

Madisonville, Kentucky, 42431, United States

Location

Medical Development Centers, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Clinical Trials of America, Inc.

Shreveport, Louisiana, 71101, United States

Location

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Charm City Research

Towson, Maryland, 21286, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02135, United States

Location

Kalamazoo Gastroenterology Hepatology

Kalamazoo, Michigan, 49048, United States

Location

Ridgeview Research Two Twelve Medical Center

Chaska, Minnesota, 55318, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

The Gastroenterology Group of S.J.

Vineland, New Jersey, 08360, United States

Location

New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

Lifeline Research Institute

Brooklyn, New York, 11214, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023, United States

Location

Gastrointestinal Research Associates, LLC

Setauket, New York, 11733, United States

Location

MediSpect, LLC

Boone, North Carolina, 28607, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

LeBauer Research Associates, P.A.

Greensboro, North Carolina, 27403, United States

Location

Clinical Trials of America, INC

Hickory, North Carolina, 28601, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Hanover Medical Specialists, PA

Wilmington, North Carolina, 28401, United States

Location

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Remington Davis

Columbus, Ohio, 43215, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45432, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Gastroenterology United of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Professional Quality Research, Inc.

Austin, Texas, 78705, United States

Location

Research Across America RHD Professional Plaza IV

Dallas, Texas, 75234, United States

Location

Houston Digestive Diseases Clinic

Houston, Texas, 77090, United States

Location

Houston Medical Research Associates

Houston, Texas, 77090, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Fatigue Consultation Clinic

Salt Lake City, Utah, 84102, United States

Location

Department of Gastroenterology University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Department of Veterans Affairs Research Department

Salt Lake City, Utah, 84148, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, 23502, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

National Clinical Research-Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Northwest Gastroenterology Associates

Bellevue, Washington, 98004, United States

Location

Radiant Research, Inc.

Lakewood, Washington, 98499, United States

Location

Wenatchee Valley Medical Center Clinical Research Dept.

Wenatchee, Washington, 98801, United States

Location

Aurora Advanced Healthcare, Inc. Clinical Research Center

Milwaukee, Wisconsin, 53209, United States

Location

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Medicor Research, Inc.

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

St. Joseph Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MedPhase Canada

Newmarket, Ontario, L3Y 8E4, Canada

Location

Meadowlands Family Health Center

Ottawa, Ontario, K2C 3R2, Canada

Location

London Road Diagnostic Clinic and Medical Center

Sarnia, Ontario, N7T 4X3, Canada

Location

PrimeHealth Clinical Research

Toronto, Ontario, M4S 1Y2, Canada

Location

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, L4L 4Y7, Canada

Location

MeSH Terms

Conditions

Constipation

Interventions

linaclotide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President, Clinical Development, Gastrointestinal
• Organization: Allergan, Inc.

IR-CTRegistration@allergan.com

1-862-261-7000

Study Officials

• Paul Eng, PhD

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 31, 2008
• Primary Completion: January 31, 2012
• Study Completion: January 31, 2012
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

US (110); CA (8)