A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Mundipharma AB160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Osteoarthritis

Interventions

Transdermal delivery systemDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr Mats Karlsson

Falköping, Parkgatan 6C, Sweden

Outcomes

Primary Outcomes

Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.

Secondary Outcomes

Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.

Data from ClinicalTrials.gov

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