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A Study Comparing Norspan Patch and Oral Tramadol

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

Summary

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.

Description

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

Conditions

Osteoarthritis

Intervention

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

Location

Seoul National University Hospital
Seoul
Korea, Republic of

Status

Completed

Source

Mundipharma Pte Ltd

Results (where available)

View Results

Links

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

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