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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BTDS 10

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

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

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

BTDS 20

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

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

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

BTDS 30

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

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.

Placebo TDS

Placebo patches were similar to BTDS 10 and 20.

Group Type PLACEBO_COMPARATOR

Placebo BTDS

Intervention Type DRUG

Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

Interventions

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Buprenorphine transdermal patch

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

Intervention Type DRUG

Buprenorphine transdermal patch

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

Intervention Type DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.

Intervention Type DRUG

Placebo BTDS

Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

Intervention Type DRUG

Other Intervention Names

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Butrans™ Butrans™ Butrans™

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No