EUCTR2010-020935-38-DE进行中（未招募）不适用
A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of diclofenac sodium topical gel 1% applied four times daily in subjects with acute ankle sprain
ovartis Consumer Health0 个研究点开始时间: 2010年9月17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. Male or female aged 18 years and over.
- •2. Acute sprain of the lateral ankle, Grade I-II.
- •3. Injury within past 12 hours.
- •4. Pain-on-movement (POM) = 50 mm on a 100 mm VAS (7.4.1 Efficacy assessment).
- •5. Satisfactory health as determined by the Investigator based on medical history and physical examination.
- •6. Give written informed consent before any assessment is performed.
- •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. Pain medication was taken within the 6 hours that precede randomization. Stable daily doses of acetylsalicylic acid (= 162 mg) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study. Treatment by rest, ice, compression, or elevation (RICE) is permitted.
- •2. Safety laboratory values with clinically significant abnormalities (as defined in Appendix 14.3). The Investigator will exercise clinical judgment in order to interpret the clinical significance of any abnormal value.
- •3. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
- •·Surgical sterilization
- •·Hormonal contraception
- •·Double barrier method
- •·Total abstinence throughout the study at the discretion of the Investigator.
- •Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
- •4. Pregnant or nursing (lactating) women.
- •5. During the past 3 months: Grade I-III sprain of the same ankle.
- •6.During the past 6 months: 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.
- •7.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- •8.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).
- •9.Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the subject.
- •10.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).
- •11.Intent to undergo surgery during time of study participation.
- •12.Any skin lesion or wound or infection in the area to be treated.
- •13.Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
- •14.History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, acetaminophen (paracetamol), acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as isopropyl alcohol or propylene glycol.
- •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 clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes.
- •18.History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
- •19.Uncontrolled psychiatric dis
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