EUCTR2006-001784-35-AT进行中（未招募）不适用
Validation of the microdialysis technique as a tool to assess local delivery of topical drugs used in the treatment of osteoarthritis of superficial joints - DicloMD
uvo research Inc0 个研究点目标入组 5 人开始时间: 2006年5月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
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. Non-smoking male or female subject aged between 18 and 40 years
- •2. Body mass index between 20 to 30 kg/m2.
- •3. Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mm Hg, heart rate between 50-99 beats/minute, temperature between 35.8 and 37.5°C after 5 min rest in supine position).
- •4. Normal laboratory values unless the investigator does not consider abnormalities to be clinically significant.
- •5. Written informed consent.
- •6. Female subjects: negative for pregnancy (as evaluated by serum ß-HCG test).
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known history of hypersensitivity to dimethyl sulfoxide and/or diclofenac sodium (e.g. Pennsaid®, Voltaren®, Arthrotec®) and/or related drugs acetylsalicylic acid (e.g. Aspirin®, Excedrin®), ibuprofen (e.g. Motrin®), dimethyl sulfoxide (e.g. Rimso® 50).
- •2. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •3. Presence of any significant physical or organ abnormality.
- •4. Presence of skin rashes, skin disorder, or skin conditions (e.g. dermatitis, eczema, psoriasis).
- •5. Significant trauma or surgery to the thigh and knee including diagnostic arthroscopy.
- •6. Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •7. Any clinically significant illness during the 4 weeks before this study.
- •8. Known skin sensitivity to topical applications.
- •9. Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
- •10. Significant or recent history of asthma (after 12 years of age).
- •11. Any subject with a history of drug abuse.
- •12. Any subject with a recent (less than 1 year) history of alcohol abuse.
- •13. Use of any prescription medication within 14 days preceding this study (except for hormonal contraceptives).
- •14. Use of Pennsaid within 30 days preceding this study.
- •15. Use of over-the-counter (OTC) medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
- •16. Female subjects: evidence of pregnancy or lactation.
- •17. Any subject who has had blood drawn within 1 month preceding this study.
- •18. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- •19. Any subject who has donated blood within 1 month preceding this study.
- •20. Any subject who has participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
- •21. Subjects who are not willing to continue their regular diet during the entire study period.
- •22. Intolerance to venipuncture or implantation of the microdialysate probe.
- •23. Allergy or hypersensitivity against NSAIDs.
- •24. Renal disease or family history of renal disease.
研究者
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