Osteoarthritis of the knee MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Trade Name: BuTrans 5 µg/h transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485797
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Newcastle Upon Tyne NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged =60 years of age 2. Subjects with a clinical diagnosis of osteoarthritis whose primary pain site is of the knee and who report pain confirmed by a pain score of =5 for average pain in the last 24 hours on a BS-11 scale and therefore require a step II medication 3. Subjects who are taking paracetemol (=2g =4g daily) with or without an NSAID. 4. Subjects who have not received a strong opioid therapy within 6 weeks of entry into the study 5. Subjects who are willing to complete QOL questionnaires and subject diaries 6. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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. Diagnosis of inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus) 2. Co-occurrence of other disabling conditions in addition to osteoarthritis likely to warrant the persistent use of escape analgesia 3. Subjects who have received an intra-articular or muscular steroid injection within 3 months of study entry or in whom such treatment is planned within the study period 4. Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period 5. Subjects recording =4 for average pain in the screening period on the BS-11 pain scale 6. Subjects with known hypersensitivity to buprenorphine or Co-Codamol tablets or any of their excipients, as outlined in the Summary of Product Characteristics for buprenorphine or Co-Codamol 7. Known hypersensitivity to other opioids or adhesives 8. Skin disease affecting application or local tolerance of BTDS 9. Clinically significant history of allergic reaction to wound dressings or elastoplast 10. Severe respiratory impairment 11. Clinically significant hepatic or renal dysfunction, subjects who LFTs and serum creatinine is outside normal recognized limits 12. Subjects who are receiving MAO inhibitors or have taken them within the previous 2 weeks 13. Subjects with myasthenia gravis 14. Subjects with convulsive disorders, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure 15. 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 16. Subjects with a known allergy or hypersensitivity to NSAIDs 17. 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 18. Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days 19. Subjects who the Investigator believes are unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of BTDS compared to co-codamol on physical activity in elderly subjects with knee pain.;Secondary Objective: To explore the effect of BTDS compared to co-codamol on average daily pain scores, sleep patterns and quality of life.;Primary end point(s): The primary endpoint will be the mean total ambulatory expenditure over a 24 hour period recorded on a NuMact ambulatory monitor. The will be fitted at Visits 1, 7 and 13 and removed after 24 hours. | — |
Countries
United Kingdom
Outcome results
None listed