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
Overview
- Phase
- Phase 4
- Intervention
- Buprenorphine Transdermal Patch
- Conditions
- Osteoarthritis
- Sponsor
- Mundipharma Pharmaceuticals Sdn. Bhd.
- Enrollment
- 78
- Locations
- 3
- Primary Endpoint
- Change in Box Scale-11 (BS-11) Pain Score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females aged 40 years and above at the time of recruitment.
- •Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint/muscle pain.
- •Having non-malignant pain of moderate intensity requiring an opioid for adequate analgesia. This was determined using BS-11 scores, where the cut-off point is ≥
- •Patients had to be opioid treatment naïve as defined by no opioid treatment (including tramadol, morphine etc.) in the preceding 1 month.
- •Patients who have uncontrolled pain and had not responded to non-opioid analgesics for 1 month or more.
- •Patients who provided informed consent.
Exclusion Criteria
- •Pregnant and lactating females.
- •Patients with chronic condition(s), in addition to (osteoarthritis) OA, that required frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
- •Patients who were awaiting a scheduled operation or other surgical procedure during study period.
- •Prior history of being on opioids in the preceding one month prior to the study for the management of chronic non-malignant pain.
- •Patients with history of allergic reactions against paracetamol/acetaminophen, Non Steroidal Anti-Inflammatory drugs (NSAIDs) and/or opioids.
- •Patients with allergies or other contraindications to transdermal systems or patch adhesives.
- •Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.
- •Patients with cancer (except for basal cell carcinoma) or history of cancer who have been diagnosed within five years prior to the visit (except for treated basal cell carcinoma).
- •Patients with conditions such as brain tumour, brain injury or raised intracranial pressure.
- •Patients with history of psychiatric disorder, uncontrollable epilepsy, untreated depression or other psychiatric disorders of a type that would make participation in the study an unacceptable risk to the patient.
Arms & Interventions
Buprenorphine Transdermal Patch
Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Intervention: Buprenorphine Transdermal Patch
Outcomes
Primary Outcomes
Change in Box Scale-11 (BS-11) Pain Score
Time Frame: Baseline,3 months
The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported. BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time.
Secondary Outcomes
- Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events(3 months)
- Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage(3 months)
- Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively(3 months)
- Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)(Baseline, 3 months)