Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement

Purdue Pharma

Status and phase: Terminated; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Placebo BTDS; Drug: Buprenorphine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403234

BUP2003

Details and patient eligibility

About

The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.

Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

Full description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
• Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.

Exclusion criteria

• Subjects who have pain or disability in a site other than the operative joint.
• Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
• Subjects whose body mass index (BMI) is 40 or more.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 4 patient groups, including a placebo group

BTDS 10

Experimental group

Description:

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

BTDS 20

Experimental group

Description:

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

BTDS 30

Experimental group

Description:

Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear

Treatment:

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Placebo TDS

Placebo Comparator group

Description:

Placebo patches were similar to BTDS 10 and 20.

Treatment:

Drug: Placebo BTDS