ISRCTN97420179已完成未知
A randomised, double-blind, placebo-controlled crossover study of the influence of the HCN channel blocker ivabradine in a healthy volunteer pain model - an enriched population study
Cambridge University Hospitals NHS Foundation trust & University of Cambridge (UK)0 个研究点目标入组 55 人开始时间: 2014年7月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31188268 (added 13/12/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Volunteers who have given written informed consent to participate
- •2. Volunteers who can communicate fluently in English
- •3. Male or female
- •4. Aged 18-64 years
- •5. Absence of any chronic pain medicine
- •6. Volunteers in good general health, including a body mass index (BMI) in the range of 19-35
- •7. Volunteers with a normal resting 12-lead standard ECG including (measured for 1 minute on lead D2): normal sinus rhythm; 60 bpm = HR on resting ECG; PR interval = 210 ms; QTcB = 430 ms for men and = 450 ms for women; QRS duration = 120 ms; the results of ECG recordings will be included in the CRF
- •8. Women of childbearing potential must use hormonal-based contraception for the duration of the trial and 1 week following the end of their trial participation
排除标准
- •1. Volunteers with one arm
- •2. Pre-existing pain on either forearm
- •3. Previous surgery or tattoo on either forearm
- •4. History of disease associated with neuropathy
- •5. Volunteers who are allergic to ivabradine or capsaicin
- •6. History of personal or familial Long QT Syndrome
- •7. History of cardiac dysrhythmia
- •8. Use of CYP3A4 inhibitors such as ketoconazole, itraconazole, macrolide antibiotics and the anti-retrovirals nelfinavir, nefazodone and ritonavir
- •9. Use of CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin or St John?s Wort etc.)
- •10. Use of QT interval prolonging medicinal products (e.g. quinidine, disopyramide or pimozide etc.)
- •11. Volunteers with any rash or broken skin on the arm where the capsaicin will be applied
- •12. Volunteers with lactose intolerance, as the placebo and ivabradine tablets contain lactose
- •13. Volunteers with a resting heart rate of 59 beats per minute or less at screening
- •14. Volunteers who are pregnant or breastfeeding
- •15. Female volunteers of childbearing potential who refuse to use hormonal contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- •16. Male volunteers who refuse to use adequate contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- •17. Volunteers who have an underlying medical condition such as migraine or epilepsy which may affect the trial findings
- •18. Volunteers who smoke (=5 cigarettes/day), take recreational drugs or consume more than the recommended allowance of alcohol units per week (21 units per week for males and 14 units per week for females)
- •19. Participants who are not willing to abstain from drinking beverages containing quinine, caffeine and/or xanthine for 24 hours prior to the trial visit
- •20. Volunteers who produce a positive result in a urine screen for drugs of abuse or who are known or suspected to be drug-dependent (sedatives, hypnotics, tranquilizers or any other addictive agent)
- •21. Volunteers who produce a positive result in an alcohol breath test
- •22. Volunteers currently participating in any interventional trial, have participated in an interventional trial within 16 weeks of screening or are currently participating in a non-interventional trial which participating in this trial would impact upon
- •23. Volunteers who, in the opinion of the PI, have a clinically relevant abnormality or medical history that is deemed to make the participant ineligible because of a safety concern
研究者
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