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

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 ≥4.
• 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.
• Patients with any conditions causing poor cognitive function as assessed by the participating physician.
• Patients with history of alcohol and drug abuse or patients who had demonstrated behaviour that suggests a dependency or drug abuse.
• Patients who were at the time taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system (CNS) depression with study medication.
• Patients who were at the time being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
• Patients who were at the time taking adjuvant analgesics such as anti-depressants (e.g. amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors (SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin).
• Patients who had received steroid treatment (intra-articular, intramuscular, oral, intravenous, epidural or other corticosteroid injections) within 6 weeks prior to clinical study or planned steroid treatment during the clinical study period.
• Patients who had to use heating facility over area of patch (examples: heating lamp, electric blanket, sauna, warm compresses, heated saline baths, etc.).
• Patients who could not or did not wish to remove hair growing at body surface where the patch can be placed.
• Any other contraindication mentioned in the Summary of Product Characteristics for Sovenor® transdermal patch.
• Patients who were at the time on disability claims or in the process of applying for disability claims.
• Patients at child-bearing age who were planning to conceive a child during the study period and were not practicing adequate contraception.
• Patients with known severe hepatic impairment as determined by liver function test within the past one year. If liver function testing was not performed within 1 year prior to study initiation, patient had to undergo liver function testing prior to recruitment.
• Patients who were at the time in or had participated in othe