Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

Phase 3TerminatedNCT00315458

Purdue Pharma LP107 enrolled

Overview

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

107

Conditions

Osteoarthritis

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine transdermal patch applied for 7-day wear.

Placebo transdermal patchDRUG

Placebo to match buprenorphine transdermal patch 10 or 20.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids. * taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain. Exclusion Criteria: * requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine. * scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/inclusion criteria may apply.

Locations (48)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) as a Measure of Safety

For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.

Time frame: 483 days

Data from ClinicalTrials.gov

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