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

Mundipharma

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Pain

Treatments: Drug: Placebo; Drug: Buprenorphine Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345787

BUP3801

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 262 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 2 patient groups, including a placebo group

0

Placebo Comparator group

Treatment:

Drug: Placebo

1

Experimental group

Treatment:

Drug: Buprenorphine Transdermal System