Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

PHASE3CompletedINTERVENTIONAL
Enrollment

439

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 (95)

11021

Long Island Clinical Research Associates, LLP, Great Neck

11023

Long Island Gastrointestinal Research Group, Great Neck

13069

Northway Medical Associates, Fulton

14642

University of Rochester, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

15401

Preferred Primary Care Physicians, Uniontown

18104

Private Practice of Dr. Hasan, Allentown

20814

Pain and Rehabilitation Medicine, Bethesda

23298

General Clinical Research Center, Virginia Commonwealth University, North Hospital, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

27103

Center for Clinical Research, LLC, Winston-Salem

27408

Medoff Medical/ Vital re:Search, Greensboro

27704

Diversified Research, Durham

28625

Carolina Pharmaceutical Research, Statesville

29406

Trident Institute of Medical Research, LLC, North Charleston

30034

Best Clinical Research, Decatur

30060

Drug Studies America, Marietta

30281

Pinnacle Trials Inc., Stockbridge

30534

North Georgia Premier Research, Dawsonville

32117

Century Clinical Research, Daytona Beach

International Medical Research, Daytona Beach

32607

Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute, Gainesville

33409

Palm Beach Research Center, West Palm Beach

33916

Clinical Physiology Associates/Clinical Study Center, Fort Myers

34613

Meridien Research, Brooksville

34711

South Lake Pain Institute, Clermont

35023

Simon Williamson Clinic, PC, Hueytown

35242

The Birmingham Pain Center, Birmingham

36608

Alabama Orthopedic Clinic, Mobile

37075

Comprehensive Pain Specialists, PLLC, Hendersonville

37232

Vanderbilt University - Interventional Pain Center, Nashville

37403

Southeastern Clinical Research, Chattanooga

38372

Integrity Clinical Research, LLC, Savannah

38801

Digestive Health Specialists, PA, Tupelo

40503

The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC, Lexington

44195

Cleveland Clinic, Cleveland

48124

Center for Clinical Studies, Dearborn

48504

Apex Medical Research, AMR, Inc., Flint

49616

Professional Clinical Research, Benzonia, Benzonia

50265

Integrated Clinical Trial Services, Inc., West Des Moines

53221

Metro Physicians a Division of Wheaton Franciscan Medical Group, Milwaukee

53295

Clement J. Zablocki VA Medical Center, Milwaukee

58501

St. Alexius Medical Center, Bismarck

60612

University of Illinois Medical Center, Chicago

61614

Redhead Research Inc., dba Research Associates of Central Illinois, Peoria

61701

Millenium Pain Center, Bloomington

70112

Tulane University Health Sciences Center, New Orleans

70808

Gulf Coast Research, LLC, Baton Rouge

71103

The Willis-Knighton Pain Management Center, Shreveport

73103

COR Clinical Research, LLC, Oklahoma City

75082

Bexar Clinical Trials, LLC, Richardson

75216

Dallas VA Research Corporation, Inc., Dallas

75234

Bexar Clinical Trials, LLC, Dallas

79761

Permian Research Foundation, Odessa

80909

Lynn Institute of the Rockies, Colorado Springs

81001

Lynn Institute of Pueblo, Pueblo

83404

Rosemark Women Care Specialists, Idaho Falls

83686

Saltzer Medical Group, Nampa

84107

Salt Lake Research, PLLC, Salt Lake City

85203

Clinical Research Advantage, Inc./ Mesa Family Medical Center, Mesa

85282

Clinical Research Advantage, Inc., Tempe

85705

Harmony Clinical Research, Inc., Tucson

85712

Quality of Life Medical & Research Center, LLC, Tucson

85741

Genova Clinical Research, Inc., Tucson

Pusch Ridge Family Medicine / WC Clinical Research, Tucson

89106

Impact Clinical Trials, Las Vegas, Las Vegas

Office of Stephen H. Miller, MD, Las Vegas

89557

University of Nevada, Reno

90036

Impact Clinical Trials, Los Angeles

90095

The Regents of the University of California, Los Angeles, Los Angeles

90807

HealthCare Partners Medical Group, Long Beach

91105

Pasadena Rehabilitation Institute, Pasadena

91910

Gregory J. Wiener, MD PC, Chula Vista

92075

SB Family Medicine, Solana Beach

92354

Loma Linda University Physicians Medical Group, Loma Linda

92653

Physicians Clinical Research Corporation, Laguna Hills

92801

Advanced Clinical Research Institute, Anaheim

Orange County Clinical Trials, Inc., Anaheim

92840

Digestive and Liver Disease Specialists, Garden Grove

92843

RX Clinical Research, Inc, Garden Grove

95831

Northern California Research Corporation, Sacramento

97219

Affinity Research, Portland

97401

Pain Research of Oregon, LLC, Eugene

85710-3539

Verona Clinical Research, Inc., Tucson

06511

Advanced Diagnostic Pain Treatment Center, New Haven

06877

International Research Clinicians of Conneticut, Ridgefield

06611

New England Research Associates, LLC, Trumbull

02115

The Brigham and Women's Hospital, Boston

08103

Cooper Health System, Camden

08084

UMDNJ, Stratford

08043

Partners in Primary Care, Voorhees Township

07069

Abraham D. Morganoff, MD PA, Watchung

02864

Partners in Clinical Research, Cumberland

02905

University Gastroenterology, Providence

L8N 3Z5

Health Sciences Center, Hamilton

All Listed Sponsors
collaborator

Sucampo Pharmaceuticals, Inc.

INDUSTRY

lead

Sucampo Pharma Americas, LLC

INDUSTRY

NCT00595946 - Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone | Biotech Hunter | Biotech Hunter