A Study Comparing Norspan Patch and Oral Tramadol

2014-08-27 03:17:45 | BioPortfolio


This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.


The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care




Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg


Seoul National University Hospital
Korea, Republic of




Mundipharma Pte Ltd

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:45-0400

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Medical and Biotech [MESH] Definitions

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An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

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