Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
Condition: Osteoarthritis; Rheumatoid Arthritis; Lower Back Pain; Joint Pain; Muscle Pain
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Arthralgia; Myalgia; Back Pain; Low Back Pain
Intervention: Buprenorphine transdermal patch
Intervention description: Please see Arm Description.
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Norspan; buprenorphine; transdermal; patch; chronic pain; non-malignant; osteoarthritis; rheumatoid arthritis; lower back pain; joint pain; muscle pain; opioid; analgesic; painkiller; Mundipharma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females aged 18-80 years (both inclusive) at the time of recruitment.

          2. Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint /
             muscle pain.

          3. Having non-malignant pain of moderate or severe intensity requiring an opioid for
             adequate analgesia (according to local label of Norspan® or Sovenor®). This is to be
             determined using BS-11 scores, where the cut-off point is ≥4.

          4. Patients with chronic uncontrolled pain and is assessed to require opioid treatment
             but have not been treated with opioids (including tramadol, morphine etc.) within 4
             weeks or more before study entry.

        Exclusion Criteria:

          1. Pregnant and lactating females.

          2. Patients with chronic condition(s), in addition to osteoarthritis, that require(s)
             frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).

          3. Patients who are awaiting a scheduled operation or other surgical procedure during
             study period or 3 months or less post-operative.

          4. Prior history of being on opioids in the preceding 1 month prior to the study for the
             management of chronic non-malignant pain.

          5. Prior history of buprenorphine transdermal system use.

          6. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs
             and/or opioids.

          7. Patients with allergies or other contraindications to transdermal systems or patch
             adhesives.

          8. Patients with dermatological disorders who may have problems applying patch or
             rotating patch placement area.

          9. Patients with cancer (except for basal cell carcinoma) or history of cancer who have
             been diagnosed within five years prior to the first study visit (except for treated
             basal cell carcinoma).

         10. Patients with conditions such as brain tumour, brain injury or raised intracranial
             pressure.

         11. 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.

         12. Patients with any conditions causing poor cognitive function as assessed by the
             participating physician.

         13. Patients with history of alcohol and drug abuse or patients who have demonstrated
             behaviour that suggests a dependency or drug abuse.

         14. Patients currently taking hypnotics or other central nervous system depressants that
             may pose a risk of additional central nervous system depression with study medication.

         15. Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) or
             have taken MAOIs within 2 weeks before screening.

         16. Patients requiring dose titration of adjuvant analgesics i.e. antidepressants (e.g.
             amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors
             (SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin). Patients will be allowed
             to enter the study as long as they are on the stable doses of adjuvant analgesics at
             screening and do not have dose adjustments during the study.

         17. Patients who have 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.

         18. Patients who have to use heating facility (examples: heating lamp, electric blanket,
             sauna, warm compresses, heated saline baths, etc.).

         19. Patients who cannot or do not wish to remove hair growing at body surface where the
             patch can be placed.

         20. Patients who are currently on disability claims or in the process of applying for
             disability claims.

         21. Patients at child-bearing age who are planning to conceive a child during the study
             period and are not practicing adequate contraception.

         22. Patients with known severe hepatic impairment as determined by liver function test
             within the past one year.

         23. Patients who are currently in or have participated in other clinical trials within the
             last 30 days prior to study recruitment.