EUCTR2007-002357-23-GB进行中（未招募）1 期
An open label, randomized 2 part crossover study to investigate the effect of buprenorphine transdermal delivery system (BTDS) compared with co-codamol on physical activity in subjects aged 60 years or over with knee pain secondary to osteoarthritis. - Effect of BTDS on physical activity in elderly subjects with knee pain secondary osteoarthritis
ewcastle Upon Tyne NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2009年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
An Open-label, Randomized, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of Aronamin-gold and VitaB 100 Tablet After Single Dosing in Healthy Male SubjectsFactors influencing health status and contact with health serviscesKCT0001628Ildong pharmaceutical24
已完成
不适用
An Open-label, Randomized, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of Aronamin-gold and Impactaminpower Tablet After Single Dosing in Healthy Male SubjectsFactors influencing health status and contact with health serviscesKCT0001419Ildong pharmaceutical24
已完成
1 期
A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.ACTRN12622000427774Emyria Ltd12
进行中（未招募）
1 期
A randomized, open label, two-way crossover study investigating the relative bioavailability of a single 5 mg dose of everolimus administered as either 5x1 mg everolimus intact tablets or 5x1 mg everolimus tablets suspended in 30 mL of water to healthy subjectsHealthy volunteersEUCTR2012-000299-40-Outside-EU/EEAovartis Pharma Services AG40
已完成
不适用
A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjectsautoimmune diseases10003816rheumatoid arthritisNL-OMON40923Hexal AG51