NCT00346047

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Mundipharma K.K. · Industry
• Sex: All
• Age: 20 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 low back pain.

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 low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Conditions

• Low Back Pain

Interventions

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

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-06-29
• Last updated: 2008-04-15

Locations

29 sites across 1 country: Japan