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

NCT05489939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3600

Last updated 2022-08-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

The compound methyl salicylate liniment

The compound methyl salicylate liniment (Ammeltz) has been developed by Japan Sendai Kobayashi Pharmaceutical Co. and has been listed in Japan for many years. It is composed of various components, such as methyl salicylate, menthol, camphor, chlorpheniramine maleate, and thymol.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Eligibility

Min Age
3 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489939 on ClinicalTrials.gov