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临床试验/NCT05489939
NCT05489939已完成不适用

Safety and Efficacy of Compound Methyl Salicylate Liniment for Topical Pain: a Multicenter Real-World Study in China

Xiangya Hospital of Central South University0 个研究点目标入组 3,600 人开始时间: 2014年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,600
主要终点
The adverse events

研究概览

简要总结

The purpose of this phase Ⅳ clinical trial was to evaluate the safety and efficacy of compound methyl salicylate liniment (Ammeltz) in a real-life environment in China. This multicenter clinical trial was conducted at 22 hospitals/centers in China between May 2014 and March 2015.

The primary aim of the trial was to evaluate the safety of Ammeltz in a real-life environment. The secondary monitoring objective was to evaluate the efficacy of Ammeltz in the treatment of soft tissue injury pain in a real-life environment.

In principle, according to the guide for drug monitoring in production enterprises in China, the number of patients included in the statistical analysis of key drug monitoring should not be less than 3000 in order to provide ample information about the trial drug. Therefore, the sample size of this study was chosen to be 3600 cases, considering the dropout rate of the subjects.

详细描述

The investigators collected demographic data, vital signs, current medical history (type of soft tissue damage), and allergy history of the eligible patients on the day of Ammeltz prescription. At the same time, a doctor conducted the physical examination and evaluated the visual analog scale (VAS) score of each patient. On the seventh day of the drug administration (one course of the treatment lasts seven days), the investigator asked each patient by telephone about the actual use of the study drug, whether adverse events occurred, and about the self-assessment pain VAS score. On the 37th day of the treatment, the patients were interviewed again by telephone to inquire about the occurrence of adverse events .

The inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain, swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in the study.

Patients were excluded if they met the following criteria: 1) allergy to any of the ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3) the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin; 4) patients without indications for the use of this drug.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The adverse events

时间窗: between May 2014 and March 2015

On the seventh and the 37th day of the drug administration (one course of the treatment lasts seven days), the investigator asked each patient by telephone whether adverse events occurred.

次要结局

  • the self-assessment pain by VAS score(between May 2014 and March 2015)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

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