NCT01161615已完成3 期
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder
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
- 350
- 主要终点
- Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.
研究概览
简要总结
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 14 years of age or older (with assent according to state law).
- •Females of child bearing potential must have a negative pregnancy test.
- •Subject has a diagnosis of acute tendonitis or bursitis of one shoulder with the onset of the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosis is indicated by a positive Hawkins Test and Neer Test, both resulting in pain with motion and the existence of shoulder impingement related to tendonitis or bursitis.
- •Subject has a Current Pain Intensity rated prior to study entry ≥ 5 but ≤ 8 on a Numeric Pain Rating Scale (NPRS) (11 point; range 0 to 10; anchors to be "none" and "severe").
排除标准
- •Subject has a suspected tear in the rotator cuff, calcific tendonitis.
- •Standard of Care (SOC) diagnosis with an AP and lateral x-ray, adhesive capsulitis, shoulder fractures, bilateral tendonitis or bursitis of the shoulders; or orthopedic surgical treatment is required.
- •Subject has a positive Drop Arm Test indicative of a suspected tear; a positive O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability.
- •Subject had a previous episode of shoulder pain in the same area within two months.
- •Subject received passive physical therapy treatments (e.g., deep heat or ultrasound) for the tendonitis/bursitis for the target shoulder within the past 24 hours; requires continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis or use of iontophoresis.
- •Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less than 3 half-lives before the baseline assessments; ibuprofen is permitted prior to baseline as long as it is not within 6 hours of the baseline assessment.
- •Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment.
- •Subject has received systemic corticosteroids in the 30 days preceding the screening visit.
- •Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants.
- •Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days.
- •Subject has a history or physical assessment finding of clinically significant.
- •GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician.
- •Subject has a history or physical assessment finding that is not compatible with safe participation in the study.
- •Subject has a pain or medical problem that in the investigator's opinion may interfere with pain measurement of the target joint.
- •Subject has active skin lesions or disease at the intended site of application of the study medication.
- •Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
- •Subject has a history of prior failed treatment with topical NSAIDs.
- •Subject has a history of drug or alcohol abuse.
- •Subject received an investigational drug within a period of 30 days prior to receiving study medication.
- •Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.
- •Subject is on workman's compensation or has pending legal hearings.
研究组 & 干预措施
Placebo
Placebo Comparator
Therapy with placebo
干预措施: Placebo (Drug)
MRX-7EAT
Experimental
Therapy with experimental drug
干预措施: MRX-7EAT (Drug)
结局指标
主要结局
Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.
时间窗: 7 days
次要结局
未报告次要终点
研究者
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