A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Mundipharma

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Transdermal delivery system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399178

BUP4009

2006-003233-32

Details and patient eligibility

About

To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OA diagnosis
• BS11 greater than or equal to 4 at base line
• Not adequately pain relieved with 4,000 mg paracetamol daily

Exclusion criteria

• Treated with high potent opioids for their OA pain
• Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
• Other chronic conditions requiring frequent analgesic therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)