Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain

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 foradequate analgesia (according to local label of Norspan® or Sovenor®). This is to bedetermined using BS-11 scores, where the cut-off point is ≥4.

4. Patients with chronic uncontrolled pain and is assessed to require opioid treatmentbut have not been treated with opioids (including tramadol, morphine etc.) within 4weeks 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 duringstudy 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 themanagement of chronic non-malignant pain.

5. Prior history of buprenorphine transdermal system use.

6. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDsand/or opioids.

7. Patients with allergies or other contraindications to transdermal systems or patchadhesives.

8. Patients with dermatological disorders who may have problems applying patch orrotating patch placement area.

9. Patients with cancer (except for basal cell carcinoma) or history of cancer who havebeen diagnosed within five years prior to the first study visit (except for treatedbasal cell carcinoma).

10. Patients with conditions such as brain tumour, brain injury or raised intracranialpressure.

11. Patients with history of psychiatric disorder, uncontrollable epilepsy, untreateddepression or other psychiatric disorders of a type that would make participation inthe study an unacceptable risk to the patient.

12. Patients with any conditions causing poor cognitive function as assessed by theparticipating physician.

13. Patients with history of alcohol and drug abuse or patients who have demonstratedbehaviour that suggests a dependency or drug abuse.

14. Patients currently taking hypnotics or other central nervous system depressants thatmay pose a risk of additional central nervous system depression with study medication.

15. Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) orhave 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 allowedto enter the study as long as they are on the stable doses of adjuvant analgesics atscreening 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 toclinical 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 thepatch can be placed.

20. Patients who are currently on disability claims or in the process of applying fordisability claims.

21. Patients at child-bearing age who are planning to conceive a child during the studyperiod and are not practicing adequate contraception.

22. Patients with known severe hepatic impairment as determined by liver function testwithin the past one year.

23. Patients who are currently in or have participated in other clinical trials within thelast 30 days prior to study recruitment.