A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Chronic PainLow Back PainAnalgesia
Interventions
DRUG

ALO-02

20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily

DRUG

Placebo

oral placebo, divided into symmetric doses and administered twice daily

Trial Locations (52)

10022

Research Across America, New York

10530

Drug Trials America, Hartsdale

12553

Mid Hudson Medical Research, PLLC, New Windsor

14221

Upstate Clinical Research Associates, LLC, Williamsville

16602

Allegheny Pain Management, PC, Altoona

16635

Altoona Center for Clinical Research, Duncansville

20636

Mid-Atlantic Medical Research - Research Department, Hollywood

27103

The Center for Clinical Research, Winston-Salem

29204

TLM Medical Services, Columbia

29406

Pain Research of Charleston, Charleston

30060

Drug Studies America, Marietta

Georgia Institute for Clinical Research, LLC, Marietta

32129

Accord Clinical Research, LLC- Duplicate 2, Port Orange

Accord Clinical Research, LLC- Duplicate, Port Orange

32174

Ormond Medical Arts pharmaceutical Research Center, Ormond Beach

32720

Avail Clinical Research, LLC, DeLand

33317

Gold Coast Research, LLC, Plantation

The Office of Martin E. Hale, MD, PA, Plantation

33409

Palm Beach Research Center, West Palm Beach

33603

Clinical Research of West Florida, Tampa

36608

Coastal Clinical Research, Inc., Mobile

43213

Columbus Clinical Research, Columbus

45227

Community Research, Cincinnati

47714

MediSphere Medical Research Center, LLC, Evansville

63141

Mercy Health Research, St Louis

68134

Heartland Clinical Research, Inc., Omaha

73112

Lynn Health Science Institute, Oklahoma City

73119

Associated Orthopedics, Oklahoma City

Hillcrest Clinical Research, Oklahoma City

75230

KRK Medical Research, Dallas

75231

FutureSearch Trials of Dallas, LP, Dallas

78209

Quality Research Inc., San Antonio

78229

Lee Medical Associates, San Antonio

Progressive Clinical Research, P.A., San Antonio

78731

FutureSearch Trials of Neurology, Austin

80904

Clinicos, LLC, Colorado Springs

80907

Lynn Institute of the Rockies Medical Centre, Colorado Springs

85023

Arizona Research Center, Phoenix

85027

Premier Research Group Limited, Phoenix

85395

Dedicated Clinical Research, Goodyear

87102

Albuquerque Clinical Trials, Inc., Albuquerque

89144

Office of Stephen H. Miller, M.D., Las Vegas

90806

Long Beach Center for Clinical Research - previous addresse, Long Beach

90807

Long Beach Center for Clinical Research, Long Beach

91606

Providence Clinical Research, North Hollywood

92637

Pacific Coast Pain Management Center, Laguna Hills

92801

Anaheim Clinical Trials, LLC, Anaheim

93710

Neuro-Pain Medical Center, Fresno

95608

Med Center, Carmichael

95628

Med Investigations, Inc., Fair Oaks

01605

Clinical Pharmacology Study Group, Worcester

02886

Omega Medical Research, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01571362 - A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain | Biotech Hunter | Biotech Hunter