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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma K.K.
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Males or females age 20 years or older.

• Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.

Exclusion Criteria:

• Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).