Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

PHASE3CompletedINTERVENTIONAL
Enrollment

909

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

March 31, 2014

Conditions
Chronic Idiopathic Constipation
Interventions
DRUG

Lubiprostone

24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA

DRUG

Lubiprostone

24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)

DRUG

Placebo

24 mcg capsules of both experimental Lubiprostone and AMITIZA

Trial Locations (93)

2131

Boston Clinical Trials Inc, Boston

2472

Bay State Clinical Trials, Inc., Watertown

11206

Hosc Inc., Brooklyn

11423

NY Scientific,189-11 Jamaica Ave, Hollis

15206

Clinical Trials Research Services, LLC, Pittsburgh

19446

Detweiler Family Medicine and Associates, PC, Lansdale

22911

Charlottesville Medical Research Center, Charlottesville

23606

Health Research of Hampton Roads, Newport News

24502

BlueRidge Medical Research, Lynchburg

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

27262

Peters Medical Research, High Point

27612

Wake Research Associates, Raleigh

28144

PMG Research of Salisbury, Salisbury

28401

PMG Research of Wilmington, Wilmington

29650

Radiant Research, Greer

30067

Atlanta Gastroenterology Assoc, Marietta

30281

Advanced Digestive Care Center , PC, Stockbridge

Clinical Research Atlanta, Stockbridge

30328

Mount Vernon Clinical Research, Atlanta

30342

Gastroenterology Consultants PC, Atlanta

32129

Accord Clinical Research,LLC, Port Orange

32174

Ormond Medical Arts Pharmaceutical, Ormond Beach

32806

Compass Research, Orlando

33012

Health Care Family Rehabilitation and Research Center, Hialeah

Medical Research Unlimited, LLC, Hialeah

33015

San Marcus Research Clinic, Miami

33126

Pharmax Research Clinic, Miami

33155

Community Research Foundation , Inc., Miami

33166

Florida International Research, Miami

33174

Columbus Clinical Services, Miami

33186

South Medical Research Group , Inc, Miami

33319

Sunrise Medical Research, Lauderdale Lakes

33426

Consultants of Clinical, Boynton Beach

33458

Health Awareness ,Inc, Jupiter

33511

PAB Clinical Research, Brandon

33563

Clinical Research of Central Florida, Plant City

33606

Meridian Research, Tampa

33709

Meridian Research, St. Petersburg

33761

Elite Trials, Clearwater

33880

Clinical Research of Central Florida, Winter Haven

34109

Pharma Research International, Inc, Naples

34110

Pharma Research International, Inc, Naples

35209

Radiant Research, Birmingham

35801

Clinical Research Associates, Huntsville

36305

Digestive Health Specialists of the Southeast, Dothan

36608

Drug Research Group, LLC, Mobile

37421

Clinsearch LLC, Chattanooga

38305

HCCA-CRS, Jackson

39202

GI Associates and Endoscopy Center, Jackson

42303

Research Integrity, Owensboro

43212

Radiant Research, Columbus

44060

Great Lakes Gastroenterology, Mentor

44122

Rapid Medical Research , Inc, Cleveland

45459

Valley Medical Research, Centerville

48047

Clinical Research Institute, Chesterfield

49009

Bayer Research, Kalamazoo

67114

Heartland Research Associates, Newton

67205

Heartland Research Associates, Wichita

68114

Quality Clinical Research, Inc, Omaha

70006

East Jefferson Gastro, Metairie

72211

Preferred Research Partners, Little Rock

75230

KRK Medical Research, Dallas

77034

Gastroenterology Consultants P.A, Houston

77074

Clinical Trial Network, Houston

77479

Breco Research, Sugarland

Pioneer Research Solutions , Inc, Sugarland

77505

Digestive Health Center, Pasadena

78205

Paragon Research Center, San Antonio

78209

Quality Research, Inc, San Antonio

78215

Sun Research, San Antonio

78238

Texas Medical Research Associates , LLC, San Antonio

80220

Horizons Clinical Research Center, Denver

80239

Radiant Research, Denver

80246

Lynn Institute of Denver, Denver

85251

Radiant Research, Scottsdale

85712

Adobe Clinical Research , LLC, Tucson

Visions Clinical Research, Tucson

85741

SC Clinical Research, Inc, Tucson

91606

Translational Research Group, North Hollywood

91786

SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204, Upland

92024

Diagnamics Inc,477 N. El Camino Real,Suite A100, Encinitas

92084

Progressive Clinical Research, Vista

92108

Medical Center for CR, San Diego

92801

Anaheim Clinical Trials, Anaheim

92868

Elias Research Associates, Orange

93710

Advanced Medical Research Institute, Fresno

93726

Research Center of Fresno, Fresno

95816

Benchmark Research, Sacramento

v

Staywell Research, Northridge

Unknown

Shawn K Hassler, San Francisco

02301

Beacon Clinical Research, Brockton

07202

Central Jersey Medical Research Center, Elizabeth

07103

University Hospital,150 Bergen Street,B-134 Pharmacy, Newark

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Dr. Reddy's Laboratories Limited

INDUSTRY