NCT01097798Unknown3 期
Multicenter, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety Aliviador Compared to Gelol in the Relief in Patients With Contusons, Sprains,Trauma and Muscle Injury.
Laboratorio Brasileiro de Biologia3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.
研究概览
简要总结
Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains, trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial pain and tendinitis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, of any race, aged over 12 years.
- •Ability to read, understand and sign the IC, in the case of minors consent of responsible;
- •Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24 hours or muscle pain, myofascial pain or tendinitis.
- •Patients able to understand and maintain the clinical protocol.
排除标准
- •Known hypersensitivity to components of the formulas of both the drug test as the comparator.
- •Known hypersensitivity to paracetamol.
- •Location of the lesion with skin wound or irritated.
- •Liver or kidney disease known.
- •Pregnant or lactating women.
- •Patients who require surgery or immobilization.
- •Patients with fractures or rupture of the ligaments.
- •Patients using anticoagulants.
- •Patients with severe concomitant systemic diseases, such as cancer, diabetes, or acquired heart disease, hematological diseases, seizure disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders.
- •History of alcoholism or illicit drug use;
- •Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of administration.
- •Conditions in the opinion of the researcher make the patient unsuitable to participate in the study.
研究组 & 干预措施
Aliviador
Experimental
干预措施: Aliviador (Drug)
Gelol
Active Comparator
干预措施: Gelol (Drug)
结局指标
主要结局
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.
时间窗: two days
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol in patients with contusions, sprains, muscle injury and trauma, starting less than 24 hours or patients with muscle pain, myofascial pain and tendinitis.
次要结局
- To evaluate the tolerability use Aliviador compared to Gelol.(two days)
研究者
研究点 (3)
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