PER-031-09已完成未知
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 17 至 75（—）
- 性别
- All
入选标准
- •Subjects male or female 17 to 75 years old
- •They suffered a mild to moderate unilateral painful ankle sprain no more than 60 hours before randomization.
- •Presence of pain of at least 50 points and not greater than 90 points on a Visual Analog Scale (VAS) 100 points at randomization
- •4 Ability and desire to comply with all procedures defined in the protocol including the filling of an electronic journal every day
排除标准
- •Open wound or infection at the site of ankle pain, or evidence of severe injury including fracture or injury to a nerve
- •Presence of any acute or chronic pain in addition to the ankle specified in the study eg. pain present due to concurrent injury occurred at the time of the sprain or a chronic condition such as osteoarthritis or gout, etc.
- •Severe ankle sprain or bilateral sprain
- •Previous injury to the same ankle within 3 months of the current injury
- •Active skin disease that includes the potential site of patch application
- •Use of aspirin (except for stable low dose prophylaxis, if started before the injury) or short-lived NSAIDs within 12 hours prior to randomization, or use of NSAIDs with a longer half-life within 24 hours before randomization
- •Use of systemic opioids within 24 hours prior to randomization, or use of topical opioids within 12 hours prior to randomization
- •Use of oral or parenteral corticosteroid medications within 30 days prior to randomization
- •Topical treatment (including physical therapy), other than RISE in English for rest, package. ice compression and simple elevation) applied in the region of pain within hours of randomization.
- •History of ulcerative peptic disease within one year of randomization, any history of gastrointestinal bleeding or coagulation abnormality (with the exception of bleeding due to internal or external hemorrhoids)
- •Clinically significant pulmonary, gastrointestinal, hepatic, renal, endocrine or cardiovascular disease, poorly controlled
- •History of intolerance or hypersensitivity including asthma, after taking aspirin or another nonsteroidal anti-inflammatory drug (NSAID) including Diclofenac
- •History of acetaminophen intolerance (study rescue medication)
- •History of skin sensitivity to adhesives (eg adhesive tape)
- •Treatment with a drug or experimental device within 30 days prior to randomization
- •Positive urine pregnancy test in women of childbearing age
- •Positive urine test for drugs of abuse
研究者
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