Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain

Mundipharma K.K.262 enrolled

Overview

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

262

Conditions

Pain Osteoarthritis

Interventions

PlaceboDRUG

Corresponding placebo is applied for 12weeks

Buprenorphine Transdermal SystemDRUG

Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females ages 40 years or older. * Clinical diagnosis of osteoarthritis (OA) of the hip or knee. Exclusion Criteria: * Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).

Locations (28)

Investigational Site

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

The time to the development of inadequate analgesia

Time frame: Up to 12weeks

Secondary Outcomes

Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores

Time frame: 12weeks

Data from ClinicalTrials.gov

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