NCT00765700已完成3 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel™ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.
研究概览
简要总结
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.
详细描述
The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age
- •Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit.
- •The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself.
- •Meet pain entry criteria.
- •Willing to discontinue use of any pain medication or treatments not provided as part of the study.
排除标准
- •Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator (e.g., nerve damage, joint instability, or tendon rupture).
- •Previous injury to the same area within 3 months prior to current injury.
- •Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury.
- •Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments.
- •Any form of opioid use since the time of injury.
- •Any form of steroid use within 30 days prior to study entry.
- •Non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) prior to the baseline visit.
- •History or physical examination finding that is not compatible with safe participation in the study as determined by the study doctor, such as gastrointestinal (stomach, intestine) ulcer or bleeding within 6 months documented by an upper-gastrointestinal series (UGI x-ray, barium meal) or endoscopy (GI scope), anemia or abnormal bleeding, moderate to severe kidney disease, or moderate to severe liver disease.
- •A history of, or evidence for, underlying disease in the injured area, such as osteoarthritis or gout.
- •Clinically significant, poorly controlled lung, stomach, liver, kidney, heart, or other vital organ disease as determined by the study doctor or nurse.
- •A history of allergy to ketoprofen or ketoprofen-containing products.
- •A history of allergy to soy lecithin or soy lecithin-containing products.
- •Medications (drugs) or other substances contraindicated due to the nature of study medication that include:
- •Allergies to prescription or over-the-counter products containing acetaminophen (e.g., Tylenol®), which is used as rescue medication
- •History of aspirin-sensitive asthma, or aspirin-associated rhinitis or nasal polyps
- •Taking warfarin, parenteral heparin, ticlopidine or clopidogrel
- •Taking lithium or methotrexate
- •Taking probenecid or similar drugs that might affect the kidneys
- •Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.
- •Scheduled elective surgery or other invasive procedures during the period of study participation.
研究组 & 干预措施
Ketoprofen 10% Cream
Active Comparator
Topical Ketoprofen 10% Cream
1gram three times daily for 7 days
干预措施: Topical Ketoprofen 10% Cream (Drug)
Placebo
Placebo Comparator
Topical placebo cream
1gram three times daily for 7 days
干预措施: Topical Placebo Cream (Drug)
结局指标
主要结局
Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.
时间窗: 7 days
次要结局
- Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.(14 days)
研究者
研究点 (1)
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