Rheumatoid Arthritis Clinical Trial
Official title:
Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia
This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics. The primary objective was to assess the efficacy of buprenorphine transdermal patch for pain control among these patients.
Buprenorphine transdermal (BTDs) is a semi-synthetic opioid analgesic. Earlier studies have
shown BTDs to be non-inferior to an oral codeine-paracetamol combination and
prolonged-release tramadol, in terms of pain control as well as sleep quality. BTDs is
registered for use in Malaysia but the scientific data on efficacy and tolerability among
Malaysians was not available. Thus, this study was conducted to evaluate the efficacy and
tolerability of BTDs among Malaysian patients.
Patients eligible for entry into the study were adults aged ≥ 40 years who met the inclusion
criteria and qualified from baseline screening and liver function test (LFT) assessment. The
study excluded patients who met the exclusion criteria and failed prior the LFT assessment.
Patients received an initial dose of 5 mg BTDs after qualifying on the baseline screening
and LFT test. The dose could be up-titrated to a maximum of BTDs 20mg (2 X 10 mg) to achieve
stable pain control.
There were six visits during the three-month study period. At visit 1, patients received 5mg
of Sovenor® as initial treatment dose. Visit 2 occurred 7 days after the first visit; visit
2 and visit 3 were dose titration visits. Visit 4 and visit 5, were for assessment purposes.
Primary treatment efficacy was measured during each visit with additional assessments of
patients' sleep quality and quality of life, while physicians' and patients' treatment
satisfaction assessed during the final visit. Safety was measured by monitoring the
occurrence of adverse events (AEs).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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