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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,559

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Chronic ConstipationIrritable Bowel Syndrome With Constipation
Interventions
DRUG

Linaclotide

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

Trial Locations (118)

11021

Long Island Clinical Research Associates, LLP, Great Neck

11023

Long Island Gastrointestinal Research Group, Great Neck

11214

Lifeline Research Institute, Brooklyn

11733

Gastrointestinal Research Associates, LLC, Setauket

15206

Clinical Trials Research Services, LLC, Pittsburgh

20815

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research, Chevy Chase

21286

Charm City Research, Towson

21742

Meritus Center for Clinical Research, Hagerstown

22911

Charlottesville Medical Research, Charlottesville

23294

National Clinical Research-Richmond, Inc., Richmond

23502

National Clinical Research - Norfolk, Inc., Norfolk

23507

Clinical Research Associates of Tidewater, Norfolk

23606

Health Research of Hampton Roads, Newport News

24073

New River Valley Research Institute, Christiansburg

27103

Digestive Health Specialists, PA, Winston-Salem

27403

LeBauer Research Associates, P.A., Greensboro

27612

Wake Research Associates, LLC, Raleigh

28304

Cumberland Research Associates, LLC, Fayetteville

28401

Hanover Medical Specialists, PA, Wilmington

28601

Clinical Trials of America, INC, Hickory

28607

MediSpect, LLC, Boone

29615

Upstate Pharmaceutical Research, Greenville

29651

Mountain View Clinical Research, Greer

Radiant Research, Greer

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30067

Atlanta Gastroenterology Associates, LLC, Marietta

30189

North Georgia Clinical Research, Woodstock

30281

Clinical Research Atlanta, Stockbridge

30342

Radiant Research, Inc., Atlanta

32168

United Medical Research, New Smyrna Beach

32405

Emerald Coast Research Associates, Panama City

32806

Compass Research, Orlando

33024

University Clinical Research, Inc., Pembroke Pines

33126

Pharmax Research Clinic, Miami

33143

Miami Research Associates, South Miami

33428

Clinical Trials Management of Boca Raton, Inc., Boca Raton

33458

Jupiter Research, Inc., Jupiter

33511

PAB Clinical Research, Brandon

33542

Florida Medical Clinic, P.A. Clinical Research Division, Zephyrhills

33606

Meridien Research, Tampa

33709

Meridien Research, St. Petersburg

33916

Clinical Physiology Associates Clinical Study Center, Fort Myers

34208

Meridien Research, Bradenton

34471

RenStar Medical Research, Ocala

34601

Meridien Research, Brooksville

34655

Advanced Research Institute, Trinity

34741

FPA Clinical Research, Kissimmee

35205

Innovative Clinical Trials, Birmingham

35215

Parkway Medical Center, Birmingham

35801

Medical Affiliated Research Center, Inc., Huntsville

37205

Nashville Medical Research Institute, Nashville

40509

Central Kentucky Research Associates, Lexington

42431

Trover Health System, Madisonville

43215

Remington Davis, Columbus

44122

Rapid Medical Research, Inc., Cleveland

45219

Consultants for Clinical Research, Cincinnati

45432

Hometown Urgent Care and Research, Dayton

47714

MediSphere Medical Research Center, LLC, Evansville

49048

Kalamazoo Gastroenterology Hepatology, Kalamazoo

52242

University of Iowa Hospitals & Clinics, Iowa City

53209

Aurora Advanced Healthcare, Inc. Clinical Research Center, Milwaukee

55318

Ridgeview Research Two Twelve Medical Center, Chaska

61107

Rockford Gastroenterology Associates, Ltd., Rockford

63128

St. Louis Center for Clinical Research, St Louis

67005

Heartland Research Associates, LLC, Arkansas City

67114

Heartland Research Associates, LLC, Newton

67205

Heartland Research Associates, LLC, Wichita

67207

Heartland Research Associates, LLC, Wichita

70808

Medical Development Centers, LLC, Baton Rouge

71101

Clinical Trials of America, Inc., Shreveport

73104

Oklahoma Foundation for Digestive Research, Oklahoma City

74135

Gastroenterology United of Tulsa, Tulsa

75234

Research Across America RHD Professional Plaza IV, Dallas

77090

Houston Digestive Diseases Clinic, Houston

Houston Medical Research Associates, Houston

77566

R/D Clinical Research, Inc., Lake Jackson

78209

Quality Research Inc., San Antonio

78229

Diagnostics Research Group, San Antonio

78705

Professional Quality Research, Inc., Austin

80033

Western States Clinical Research, Wheat Ridge

80205

Colorado Gastroenterology, Prof LLC, Denver

80304

Boulder Medical Center, P.C., Boulder

80501

Longmont Medical Research Network, Longmont

80907

Lynn Institute of the Rockies, Colorado Springs

83404

Rosemark WomenCare Specialist, Idaho Falls

84102

Fatigue Consultation Clinic, Salt Lake City

84132

Department of Gastroenterology University of Utah Hospital, Salt Lake City

84148

Department of Veterans Affairs Research Department, Salt Lake City

85012

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

85018

Elite Clinical Studies, LLC, Phoenix

85224

Radiant Research, Inc., Chandler

85251

Radiant Research, Inc., Scottsdale

85381

Pivotal Research Centers, Peoria

Pivotal Research Center, Peoria

85704

Genova Clinical Research, Inc., Tucson

85712

Adobe Clinical Research, LLC, Tucson

87106

New Mexico Clinical Research and Osteoporosis Center, Albuquerque

90036

Axis Clinical Trials, Los Angeles

91345

Facey Medical Foundation, Mission Hills

91361

Westlake Medical Research, Westlake Village

91505

Providence Clinical Research, Burbank

92024

Encompass Clinical Research North Coast, Encinitas

92610

Family Medical Center, Foothill Ranch

92869

Advanced Clinical Research Institute, Orange

98004

Northwest Gastroenterology Associates, Bellevue

98499

Radiant Research, Inc., Lakewood

98801

Wenatchee Valley Medical Center Clinical Research Dept., Wenatchee

06708

Chase Medical Research, LLC, Waterbury

02135

Boston Clinical Trials, Boston

08360

The Gastroenterology Group of S.J., Vineland

V6Z 2K5

GI Research Institute, Vancouver

P3E 1H5

Medicor Research, Inc., Greater Sudbury

L8N 4A6

St. Joseph Healthcare, Hamilton

L3Y 8E4

MedPhase Canada, Newmarket

K2C 3R2

Meadowlands Family Health Center, Ottawa

N7T 4X3

London Road Diagnostic Clinic and Medical Center, Sarnia

M4S 1Y2

PrimeHealth Clinical Research, Toronto

L4L 4Y7

Toronto Digestive Disease Associates, Inc., Vaughan

Sponsors
All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY