Status:
COMPLETED
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
Lead Sponsor:
Mundipharma K.K.
Conditions:
Low Back Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00346047
Start Date
May 1 2006
End Date
July 1 2007
Last Update
April 15 2008
Active Locations (29)
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1
Investigational Site
Ichikawa, Chiba, Japan
2
Investigational Site
Matsudo, Chiba, Japan
3
Investigational Site
Noda, Chiba, Japan
4
Investigational Site
Asakura, Fukuoka, Japan