NCT01019265

A Study Comparing Norspan Patch and Oral Tramadol

A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Mundipharma Korea Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

Detailed 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 (slow release) 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg	Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2009-11-25
• Last updated: 2015-07-08

Locations

5 sites across 1 country: South Korea