Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

395

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Chronic Noncancer Pain
Interventions
DRUG

oxycodone HCl and naltrexone HCl extended-release capsules

Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Trial Locations (32)

10530

Drug Trials America - New York, Hartsdale

13212

New York Spine and Wellness Center, North Syracuse

14221

Upstate Clinical Research Associates, Williamsville

16602

Allegheny Pain Management, PC, Altoona

21117

Crossroads Research, Owings Mills

24018

Hypothetest, LLC, Roanoke

27103

Center for Clinical Research, LLC - Winston-Salem, Winston-Salem

30060

Drug Studies America, Marietta

Georgia Institute for Clinical Research, LLC, Marietta

30327

Center for Prospective Outcome Studies, Inc., Atlanta

32129

Accord Clinical Research, Port Orange

32174

Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach

Peninsula Research, Inc., Ormond Beach

32257

Florida Institute of Medical Research, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

33458

Drug Study Institute, Jupiter

33603

Clinical Research of West Florida, Tampa

34238

Sarasota Pain Medicine Research, Sarasota

38671

Mid-South Anesthesia Consultants, Southaven

40503

The Pain Treatment Center of the Bluegrass, Lexington

42431

Commonwealth Biomedical Research, Madisonville

43213

Columbus Clinical Research, Inc., Columbus

55435

MAPS Applied Research Center, Edina

59802

Montana Neuroscience Institute, Missoula

64042

Healthcare Research, LLC, Hazelwood

75230

KRK Medical Research, Dallas

76135

Benchmark Research - Fort Worth, Fort Worth

78209

Quality Research, Inc., San Antonio

78731

FutureSearch Trials of Neurology, Austin

84106

Lifetree Clinical Research, Salt Lake City

01103

DM Clinical Research, Springfield

08009

Comprehensive Clinical Research, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01428583 - Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain | Biotech Hunter | Biotech Hunter