Rheumatoid Arthritis Clinical Trial
Official title:
Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For Analgesia
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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