Severe osteoarthritic pain of the hip(s) and/or knee(s) MedDRA version: 8.0 Level: PT Classification code 10003239
Conditions
Interventions
Product Name: Butrans 5 micrograms/h Transdermal Patch
Product Code: BTDS 5
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine
Sponsors
Napp Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex aged 60 years or above 2. Subjects with a clinical diagnosis of osteoarthritis whose primary pain site is of the hip(s) and/or knee(s) and who report severe osteoarthritic pain confirmed by a score of = 5 for average pain in the last 24 hours on a BS11 pain scale and therefore require a step II medication 3. Concurrent medication. Subjects must be taking a maximum tolerated dose of paracetamol (=4 500 mg tablets daily) and may or may not be taking additional NSAID medication 4. Subjects who have not received strong opioid therapy within 6 weeks of entry into the study 5. Subjects who are willing and able to complete quality of life questionnaires and a daily subject diary 6. Subjects who give written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with any painful disease of the joints, other than osteoarthritis e.g. gout, rheumatoid arthritis, ankylosing spondylitis etc 2. Subjects with any chronic painful condition other than osteoarthritis, likely to warrant the persistent use of escape analgesics 3. Subjects scheduled for elective surgery of the disease site (e.g. major joint replacement surgery), or any other elective major surgery, which would fall within the study period 4. Subjects recording below 5 for average pain in the last 24 hours on the BS11 pain scale 5. Subjects who have received an intra-articular steroid injection within six weeks of entering the study, or in whom such therapy is planned within the study period 6. Subjects with a known allergy, hypersensitivity or other contraindication to buprenorphine or other opioids, transdermal delivery systems or patch adhesives or to NSAIDS 7. Subjects taking COX II selective inhibitors 8. Subjects currently taking monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within two weeks of entering the study 9. Subjects taking hypnotics, anxiolytics, selective serotonin re-uptake inhibitors (SSRIs) or tricyclic antidepressants whom, in the investigator's opinion, there may be a risk of additional CNS depressant effects with the opioid components of the study medication 10. Subjects with clinically significant respiratory depression; cardiac, hepatic or renal insufficiency; or obstructive airways disease in whom, in the opinion of the investigator, the use of opioids would be contra-indicated 11. Subjects with a history of asthma in whom, in the opinion of the investigator, the administration of an opioid may precipitate an acute asthmatic attack 12. Subjects at risk of seizures or who have a history of seizures or who are receiving concomitant anticonvulsant therapy for epilepsy or a history of convulsive disorders 13. Subjects with a history of depression or other psychiatric disorder that in the opinion of the investigator are significant enough to exclude the subject from the study 14. Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse or who, in the investigator’s opinion, have previously demonstrated drug-seeking behaviour 15. Subjects who have participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry 16. Subjects with evidence of raised intracranial pressure or head injury 17. Subjects with a history of or current myasthenia gravis 18. Subjects who, for the study period, require and cannot discontinue therapy which involves direct external heat sources such as heat lamps, electric blankets, saunas, heating pads and heated water beds 19. Subjects with any dermatological disorder at any relevant patch application site 20. Subjects with hairy areas who cannot or will not cut the hair at the patch site for proper placement of the patch 21. Any other contraindications listed on the Summary of Product Characteristics for BTDS or Cocodamol tablets 22. Subjects whom the investigator believes to be medically unfit to receive the study medic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess average daily pain intensity. The mean BS-11 pain scores recorded during the study will be calculated for each subject during the last week of the titration period and for each two week interval of the assessment period will be calcuated from the average daily pain score recorded on a BS-11 pain scale every evening, in the subject diaries.; Secondary Objective: To assess the optimum method of titration by looking at: Time to achieve stable pain control Length of time on anti-emetics Dicontinuation of subjects in the titration period Escape medication use (ibuprofen dose/day) during the last week of the titration period and each two week interval of the assessment period will be calculated Sleep Scale completed by all subjects at study entry and at completion of the assessment period or discontinuation from the study Laxative use Exploratory measures: WOMAC Osteoarthritis Index Treatment Satisfaction Questionnaire for Medication (TSQM) Health Status Questionnaire (General Well-being Index and EuroQol EQ-5D Questionnaire) Health Care Resource Utilisation Patch durability ;Primary end point(s): The primary efficacy measure will be the average daily pain score recorded on a BS-11 pain scale in subjects diaries every evening before going to bed. | — |
Countries
United Kingdom
Outcome results
None listed