NCT02519387

Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Mundipharma Pharmaceuticals Sdn. Bhd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Lower Back Pain
• Joint Pain
• Muscle Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine Transdermal Patch

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-08-10
• Last updated: 2016-07-20
• Results posted: 2016-07-20

Locations

3 sites across 1 country: Malaysia