EUCTR2005-004279-39-GB进行中（未招募）1 期
An open, randomised, multicentre study to compare buprenorphine transdermal delivery system (BTDS) with standard treatment in elderly subjects with OA of the hip and/or knee.
app Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
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