A Study Comparing Norspan Patch and Oral Tramadol

Mundipharma

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01019265

BUP07-KR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.