A Study Comparing Norspan Patch and Oral Tramadol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Norspan patch (Buprenorphine TDS)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

TramadolSR tab (Tridol SR tab)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

Interventions

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

Comparing pain intensity between intervention drugs (Norspan® and Tridol®)

Intervention Type DRUG

Other Intervention Names

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Norspan patch Buprenorphine transdermal system (BTDS)

Eligibility Criteria

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Inclusion Criteria

* Males and females aged more than 18 years.
* Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
* Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.

Exclusion Criteria

* Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
* Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
* Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No