IRCT138807012498N1已完成3 期
Combined nonsteroidal anti-inflammatory drug, muscle relaxant, and caffeine versus nonsteroidal anti-inflammatory drug or mucle relaxant monotherapy for acute mechanical low back and/or cervical pain. A double blind, randomized, multicenter, phase III study.
Ache Laboratories0 个研究点目标入组 714 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 714
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
- 18 years 至 65 years（—）
- 性别
- Male
入选标准
- •Inclusion criteria
- •-Male or female subjects, 18 to 65 years of age
- •-Written informed consent
- •-Having acute mechanical lower back and/or cervical pain
- •-VAS score minimum of 50 mm at time of entry into study.
- •Exclusion criteria
- •-Subject is pregnant or lactating woman , or a woman of childbearing potential not using an acceptable method of contraception
- •-Medical history or physical examination results that suggest the pain, symptoms or signs are caused by a serious medical condition (e.g., fever in the last days, diabetes, cancer, rheumatic diseases, cardiac, liver, renal diseases)
- •-History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs,
- •-Known allergies, hypersensitivity, or intolerance to any drugs used in the study
- •-Known or suspected history of alcohol or drug abuse
- •-History of epilepsy or recurrent seizures
- •-Creatinine > 1.3 mg/dl
排除标准
- 未提供
研究者
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