NCT00315445 - The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. | Biotech Hunter

Enrollment

134

Participants

Timeline

Start Date

December 31, 1997

Primary Completion Date

May 31, 1998

Study Completion Date

May 31, 1998

Conditions

Back Pain

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.

DRUG

Placebo oxycodone/acetaminophen tablets

Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

DRUG

OXY/APAP

5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

DRUG

Placebo transdermal patch (TDS)

Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Trial Locations (12)

27607

North Carolina Clinical Research, Inc., Raleigh

30033

Atlanta Research Center, Decatur

32605

Gainesville Clinical Research Center, Gainesville

33134

SeaView Research, Miami

33324

Park Place Therapeutic Center, Plantation

35801

Rheumatology Associates of North Alabama, Huntsville

64114

The Center for Pharmaceutical Research, P.C., Kansas City

75234

Research Across America, Dallas

75235

Metroplex Clinical Research Center, Dallas

85015

Phoenix Center for Clinical Research, Phoenix

85023

Phoenix Orthopedic Center, Ltd., Phoenix

08221

New Jersey Research Foundation, Linwood

All Listed Sponsors

lead

Purdue Pharma LP

INDUSTRY