Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-10-31

Study Completion Date

1997-11-30

Brief Summary

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The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.

Detailed Description

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Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Conditions

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Postoperative Pain

Keywords

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postoperative pain opioid transdermal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine transdermal delivery system

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively.
* in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.

Exclusion Criteria

* receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents.
* have significant concurrent pulmonary conditions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Park Place Therapeutic Center

Plantation, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BP96-0104

Identifier Type: -

Identifier Source: org_study_id