Conditions: Osteoarthritis Rheumatoid Arthritis Lower Back Pain Joint Pain Muscle Pain
Keywords: Norspan buprenorphine transdermal patch chronic pain non-malignant osteoarthritis rheumatoid arthritis lower back pain joint pain muscle pain opioid analgesic painkiller Mundipharma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, who are not adequately responding to non-opioid painkillers.

Detailed description:
Baseline assessment (Visit 1) includes medical history, physical examination, vital signs.

At Visit 2 \[7 days ( ± 3 days) after Visit 1\] and subsequent optional titration visits up to (Visit 1 + 42 days) , patients will be titrated up to an effective and tolerated dose of Norspan® or Sovenor® transdermal patch and continue rescue analgesic, if necessary.

Titration period is dependent on time to achieving optimal pain control as determined by the investigator. The up-titration regime is planned on a weekly basis. Earlier dose titration (i.e. minimum 3 days after the patch application) is permitted at the investigator's discretion if the pain is uncontrolled. Effective and tolerated dose is assessed by data recorded in the case report form and patient diary.

According to country label, all patients will begin treatment with Norspan® or Sovenor® transdermal patch 5mg and will then be up-titrated, if necessary, to a maximum of Norspan® or Sovenor® transdermal patch 40mg or according to country label to achieve stable pain control. Patients that require oral opioid at any time during the study should be discontinued from the trial.

Arms:
arm 1: Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.

Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Please see Arm Description.

Protocol document: