Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
Phase 3
Completed
- Conditions
- Low Back Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT00346047
- Lead Sponsor
- Mundipharma K.K.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0 Placebo - 1 Buprenorphine Transdermal System -
- Primary Outcome Measures
Name Time Method The time to the development of inadequate analgesia. Up to 12weeks
- Secondary Outcome Measures
Name Time Method Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores Up to 12 weeks
Trial Locations
- Locations (1)
Investigational Site
🇯🇵Osaka, Japan