EUCTR2007-003797-25-DE进行中（未招募）不适用
A randomized, double-blind, multi-center, vehicle-controlled, parallel group study to evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel applied once or twice daily in subjects with acute ankle sprain
ovartis Consumer Health SA0 个研究点开始时间: 2009年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
入选标准
- •1. Males or females aged 18 to 75 years.
- •2. If Women of Child Bearing Potential (WOCBP), i.e., not > 1 year postmenopausal or surgically sterilized, agreement to maintain an effective method of contraception throughout the study.
- •WOCBP include all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal:
- •? 12 months of natural (spontaneous) amenorrhea,
- •? 6 months of spontaneous amenorrhea with serum FSH levels > 40 IU/mL, or
- •? 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
- •WOCBP must use one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may also include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study.
- •WOCBP must have negative urine pregnancy tests at screening and baseline.
- •3. Acute sprain of the lateral ankle, Grade I-II
- •4. Injury within past 48 hours.
- •5. No pain medication taken since the injury (RICE authorized prior to randomization) - pain medication taken prior to the injury must be washed out
- •6. Assessment of POM = 50 mm on a 100 mm VAS
- •7. Satisfactory health as determined by the investigator based on medical history and physical examination.
- •8. Explicit agreement to follow study procedures, in particular concerning study medication (twice daily), concomitant medication (no other painkillers), diary entries (daily), and study visits (availability at all dates).
- •9. Voluntarily sign and date the ICF, approved by an IRB/IEC, prior to the conduct of any study specific procedures.
- •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. Grade III ankle sprain and/or any concurrent injury concerning the lower extremities that is painful at rest or on movement, or might affect the mobilization of the subject.
- •2. Any pain medication taken since the injury or washout requirement for oral pain medication not respected. Stable dose of aspirin (= 162 mg) for non analgesic reasons for at least 30 days prior to the first dose of study medication are permitted to be continued for the duration of the study.
- •3. Topical analgesic or anti inflammatory treatment in the area to be treated over the previous month.
- •4. Grade I sprain of the same ankle during the past 3 months.
- •5. Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails), of the same ankle or foot, during the past 6 months.
- •6. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- •7. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
- •8. Any skin lesion or wound in area to be treated.
- •9. Intent to undergo surgery or concomitant physiotherapy (including, but not exclusive to, TENS, massage, and spinal manipulation) or any other kind of pain therapy throughout the course of the study.
- •10. Pregnancy, nursing, or WOCBP not practicing effective contraceptive methods.
- •11. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, aspirin, methylsalicylate, other NSAID or COXIB.
- •12. Known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as oleyl alcohol, isopropyl alcohol, or propylene glycol.
- •13. Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation, including AST or ALT > 3, or BUN > 1.5 times the upper limit of the reference range, or creatinine > 1.5 mg/dL.
- •14. Any known active malignancy. A history of malignancy which was successfully treated, without evidence of recurrence, is acceptable.
- •15. Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect.
- •16. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
- •17. History of uncontrolled chronic or acute concomitant disease which, in the investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
- •18. Pending worker’s compensation claim, litigation, or any other monetary settlement claim.
- •19. Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse.
- •20. Positive urine pregnancy test.
- •21. Positive urine drug screen test.
- •22. Previous participation in this clinical study.
- •23. Participation in any other clinical study within 30 days of the screening visit.
- •24. Any physical impairment that would influence the study's efficacy evaluations, in particular POM and the Ankle Joint Function, such as: peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees, or feet, or any painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart).
- •25. Any cognitive impairment that would, in the opinion of the investigator, preclude study participatio
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