Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

905

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

October 31, 2013

Conditions
Chronic Low Back Pain
Interventions
DRUG

Hydrocodone bitartrate q24h film-coated tablets

Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

DRUG

Placebo to match hydrocodone bitartrate q24h tablets

Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Trial Locations (102)

10128

The Medical Research Network, LLC, New York

10530

Drug Trials America, Hartsdale

14221

Upstate Clinical Research Associates, Williamsville

14618

Finger Lakes Clinical Research, Rochester

16602

Allegheny Pain Management, P.C., Altoona

16684

Tipton Medical & Diagnostic Center, Tipton

19139

CRI Worldwide, LLC, Philadelphia

19152

Founders Research Corporation, Philadelphia

21204

IRC Clinics, Inc., Towson

24018

HypotheTest, LLC, Roanoke

27103

Clinical Trials of America, Inc., Winston-Salem

The Center for Clinical Research, Winston-Salem

28209

PMG Research of Charlotte, LLC, Charlotte

28401

PMG Research of Wilmington LLC, Wilmington

29621

Hartwell Research Group, Anderson

29651

Radiant Research, Inc., Greer

30060

Georgia Institute for Clinical Research, LLC, Marietta

Taylor Research, LLC, Marietta

30265

Better Health Clinical Research, Inc., Newnan

30281

Atlanta Knee and Shoulder Clinic, PC, Stockbridge

31904

Southeast Regional Research Group, Columbus

32174

Peninsula Research Inc., Ormond Beach

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32720

Avail Clinical Research, LLC, DeLand

32806

Clinical Neuroscience Solutions, Inc., Orlando

Compass Research, LLC, Orlando

33012

AGA Clinical Trials, Hialeah

33176

Neuroscience Consultants LLC, Miami

33183

International Research Associates, LLC, Miami

33312

Florida Health Center, Fort Lauderdale

33317

Gold Coast Research, LLC, Plantation

33319

Fidelity Clinical Research, Inc., Lauderhill

33458

Health Awareness, Inc., Jupiter

33472

Orthopedic Research Institute, Boynton Beach

33603

Clinical Research of West Florida, Inc., Tampa

33756

Innovative Research of West Florida, Inc., Clearwater

33781

Advent Clinical Research Centers, Inc., Pinellas Park

33916

Clinical Physiology Associates, Fort Myers

34208

Meridien Research, Bradenton

34243

Sarasota Research, LLC, Sarasota

34677

Journey Research, Inc, Oldsmar

35213

Alliance Clinical Research, Birmingham

36608

Coastal Clinical Research, Inc., Mobile

37075

Comprehensive Pain Specialists, LLC, Hendersonville

37167

HCCA Clinical Research Solutions, Smyrna

37825

Heartland Medical, PC, New Tazewell

38119

Clinical Neuroscience Solutions, Inc., Memphis

41017

Community Research, Crestview Hills

42431

Commonwealth Biomedical Research, LLC, Madisonville

43623

Bone Joint and Spine Surgeons, Inc., Toledo

44313

Daystar Clinical Research, Inc., Akron

45245

IVA Research, Cincinnati

45255

Community Research, Cincinnati

46250

Rehabilitation Associates of Indiana, Indianapolis

46383

Northwest Indiana Center for Clinical Research, Valparaiso

48025

QUEST Research Institute, Bingham Farms

49684

Medical Research Associates, Inc., Traverse City

50265

Integrated Clinical Trial Services, Inc., West Des Moines

57702

Health Concepts, Rapid City

60622

Illinois Center for Clinical Research, Chicago

63042

Healthcare Research Network, Hazelwood

63117

Medex Healthcare Research, Inc., St Louis

63128

Advance Clinical Research, St Louis

63141

Mercy Health Research, St Louis

Sundance Clinical Research, LLC, St Louis

66210

ICRI, Overland Park

68114

Quality Clinical Research, Omaha

70114

Louisiana Research Associates, Inc., New Orleans

73116

Cutting Edge Research Group, Oklahoma City

75230

KRK Medical Research, Dallas

77008

Heights Doctor's Clinic, Houston

77566

R/D Clinical Research, Inc., Lake Jackson

78215

Sun Research Institute, San Antonio

78731

FutureSearch Trials of Neurology, Austin

84058

Aspen Clinical Research, Orem

84088

Advanced Clinical Research, West Jordan

85023

Arizona Research Center, Phoenix

85029

Redpoint Research, Phoenix

85704

Genova Clinical Research, Tucson

85712

Quality of Life Medical & Research Center, LLC, Tucson

Redpoint Research, Tucson

87102

Albuquerque Clinical Trials, Inc., Albuquerque

87108

Lovelace Scientific Resources, Albuquerque

89123

Advanced Biomedical Research of America, Las Vegas

89144

Research Facility, Las Vegas

90717

Torrance Clinical Research Institute Inc., Lomita

90806

Skyline Research, LLC, Long Beach

91942

TriWest Research Associates, La Mesa

91978

Encompass Clinical Research, Spring Valley

92801

Orange County Research Institute, Anaheim

92804

United Clinical Research Center, Inc., Anaheim

93726

Research Center of Fresno, Inc., Fresno

94806

Center for Clinical Research, Inc., Richmond

95821

Northern California Research, Sacramento

98007

Northwest Clinical Research Center, Bellevue

98026

Washington Center for Pain Management, Edmonds

92801-2417

ACRI-Phase 1, LLC, Anaheim

06708

Chase Medical Research, LLC, Waterbury

02301

Beacon Clinical Research, LLC, Brockton

02472-3930

MedVadis Research Corporation, Watertown

08009

Comprehensive Clinical Research, Berlin

08046

CRI Worldwide LLC, Willingboro

All Listed Sponsors
lead

Purdue Pharma LP

INDUSTRY

NCT01452529 - Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain | Biotech Hunter | Biotech Hunter