NCT00345787

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

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Mundipharma K.K. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pain
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Placebo	Corresponding placebo is applied for 12weeks
DRUG	Buprenorphine Transdermal System	Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-06-29
• Last updated: 2008-04-15

Locations

28 sites across 1 country: Japan