Status:
COMPLETED
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain
Lead Sponsor:
Mundipharma K.K.
Conditions:
Pain
Osteoarthritis
Eligibility:
All Genders
40+ 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 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...
Eligibility Criteria
Inclusion
- Males or females ages 40 years or older.
- Clinical diagnosis of osteoarthritis (OA) of the hip or knee.
Exclusion
- Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00345787
Start Date
May 1 2006
End Date
August 1 2007
Last Update
April 15 2008
Active Locations (28)
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1
Investigational Site
Nagoya, Aichi-ken, Japan
2
Investigational Site
Okazaki, Aichi-ken, Japan
3
Investigational Site
Ichikawa, Chiba, Japan
4
Investigational Site
Matsudo, Chiba, Japan