Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

PHASE3CompletedINTERVENTIONAL
Enrollment

437

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Opioid-Induced Bowel Dysfunction
Interventions
DRUG

Lubiprostone

24 mcg capsules twice daily (BID)

DRUG

Placebo

0 mcg capsules twice daily (BID)

Trial Locations (114)

10004

Medex Healthcare Research, Inc., New York

10016

New York University Pain Management Center, New York

10022

Research Across America, New York

11580

North American Partners, Valley Stream

14221

Upstate Clinical Research Associates, Williamsville

18103

Lehigh Valley Hospital - Neurosciences and Pain Research, Allentown

19067

Jeffry A. Lindenbaum DO, PC, Yardley

19414

Einstein Pain Institute, Philadelphia

21045

Columbia Medical Practice/ RxTrials, Inc., Columbia

21228

Rehabilitation Team West, PA, Baltimore

21742

Washington County Hospital Association - The Center for Clinical Research, Hagerstown

23249

McGuire Research Institute, Richmond

23707

Hampton Roads Institute for Performance and Sports Medicine (HIPS), Portsmouth

24073

New River Valley Research Institute, Christiansburg

27203

Randolph Medical Associates, Asheboro

27262

Peters Medical Research, LLC, High Point

27295

Triangle Medical Research, Lexington

27710

Duke University Medical Center, Durham

27834

Carolina Research, Greenville

28075

Carolina Digestive Health Associates, Harrisburg

28562

Southern Gastroenterology Associates, New Bern

30035

Q Clinical Research, Decatur

30701

Global Research Partners & Consultants, Incs., Calhoun

30901

Advanced Pain Management, Augusta

32129

Accord Clinical Research, LLC, Port Orange

32174

Peninsula Research, Inc, Ormond Beach

32257

Florida Institute of Medical Research, Jacksonville

32578

Kenneth W. Ponder, MD PA, Niceville

33161

North Miami Research, Inc., North Miami

33324

Sunrise Medical Research, Inc., Plantation

33458

Drug Study Institute, Jupiter

33486

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

33603

Clinical Research of West Florida, Inc., Tampa

33613

Stedman Clinical Trials, Tampa

33709

Meridien Research, St. Petersburg

33782

DMI Research, Inc., Pinellas Park

34102

Gastroenterology Group of Naples, Naples

34233

Lovelace Scientific Resources, Inc., Sarasota

34471

Renstar Inc., Ocala

35404

Tuscaloosa VA Medical Center, Tuscaloosa

37920

Baptist Medical Tower Suite 740, Knoxville

38358

Integrity Clinical Research, LLC, Milan

39232

Precise Research, Inc., Flowood

40202

University of Louisville, Louisville

43302

RAS Health Ltd., Marion

43614

University of Toledo - Health Science Campus, Toledo

45238

Glenway Family Medicine, Cincinnati

45432

Urgent Care Specialists, Dayton

45459

Valley Medical Primary Care, Centerville

46260

Davis Clinic, PC, Indianapolis

47630

Advanced Pain Care Clinic, Evansville

47714

MediSphere Medical Research Center, Evansville

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48098

Center for Digestive Health, Troy

48917

PCM Medical Services, Lansing

49079

Women's Health Care Specialists, PC, Paw Paw

49643

Professional Clinical Research, Inc., Interlochen

49684

Medical Research Associates, Traverse City

55435

MAPS Applied Research Center, Edina

55905

Mayo Clinic, Rochester

59802

Montana Neuroscience Institute Foundation / Montana Spine and Pain Center, Missoula

60616

Apex Medical Research, AMR, Inc., Chicago

60617

Claude Mandel Medical Center, Chicago

63117

Medex Healthcare Research, St Louis

66160

University of Kansas Medical Center, Kansas City

68131

Creighton University Medical Center, Omaha

70503

Gulf Coast Research, LLC, Lafayette

71103

Louisiana Research Center, LLC, Shreveport

71201

Delta Research Partners, LLC, Monroe

72205

Martin Bowen Hefley Knee, Little Rock

73112

Lynn Health Science Institute, Oklahoma City

Paradigm Research Professionals, LLP, Oklahoma City

73134

Memorial Clinical Research, Oklahoma City

75082

Bexar Clinical Trials, LLC, Richardson

75605

DCOL Center for Clinical Research, Longview

76054

Texas Familicare Clinical Research, Hurst

80120

Arapahoe Gastroenterology, PC, Littleton

80122

Metro Clinical Research, LLC, Littleton

80215

Rocky Mountain Gastroenterology Associates, Lakewood

80904

Clinicos, LLC, Colorado Springs

84124

Highland Clinical Research, Salt Lake City

84405

Advance Research Institute, Ogden

85012

Carl T Hayden VA Medical Center, Phoenix

85029

Redpoint Research, Phoenix

85050

HOPE Research Institute, LLC, Phoenix

85222

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC, Tempe

85282

Premiere Pharamaceutical Research, LLC, Tempe

85705

Harmony Clinical Research, Inc., Tucson

89123

Advanced Biomedical Research of America, Las Vegas

89146

Lovelace Scientific Resources, Inc., Las Vegas

91007

Advanced Pain Institute, Arcadia

91710

Catalina Research Institute, LLC, Chino

92354

Loma Linda University Physicians Medical Group, Loma Linda

92637

Shreenath Clinical Service, Laguna Hills

92647

California Pain Center, Huntington Beach

93311

Pain Institute of CA, Bakersfield

94117

Rider Research Group, San Francisco

97504

Medford Medical Clinic, LLP, Medford

98004

Northwest Gastroenterology Associates, Bellevue

99204

Daniel R. Coulston, Spokane

90822-5201

VA Long Beach Healthcare System, Long Beach

02215

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston

02481

MedVadis Research Corporation, Wellesley Hills

07927

Gastroenterology Research Associates, Cedar Knolls

07202

Central Jersey Medical Research Center, Elizabeth

07666

Holy Name Hospital, Institute for Clinical Research, Teaneck

08043

Advanced Pain Consultants, Voorhees Township

43210-1228

The Ohio State University Medical Center, Columbus

84132-2410

University of Utah, Salt Lake City

T5A 4L8

Hermitage Medicentre, Edmonton

R3A 1R9

Health Sciences Centre, Winnipeg

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

N5X4E7

Pharmaceutical Integrated Research Company, London

L4B 3P8

DHC Research, Richmond Hill

All Listed Sponsors
collaborator

Sucampo Pharmaceuticals, Inc.

INDUSTRY

lead

Sucampo Pharma Americas, LLC

INDUSTRY

NCT00597428 - Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone | Biotech Hunter | Biotech Hunter