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Clinical Drug Investigation
Published in: Clinical Drug Investigation 4/2019

Open Access 01-04-2019 | Myalgie | Original Research Article

Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial

Authors: Dongbao Zhao, Zhiwei Chen, Shaoxian Hu, Jianhao Lin, Zengwu Shao, Guochun Wang, Weiguo Xiao, Yi Zheng, Zhiyi Zhang, Yeqing Shi, Zhanguo Li

Published in: Clinical Drug Investigation | Issue 4/2019

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Abstract

Background and Objective

Loxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia.

Methods

In this double-blind, double-dummy, parallel-group, randomized controlled trial, 182 Chinese patients were enrolled and randomized equally to either LOX-T or LOX-O treatment for 2 weeks. Patients in the LOX-T group applied one sheet of the active LOX-T once a day on the affected site and took one placebo tablet three times a day immediately after meals, whereas patients in the LOX-O group applied one sheet of the placebo patch once a day and took one active LOX-O three times a day. Primary endpoint was the proportion of patients with 50% overall improvement or higher at the final visit. The cutoff value of a non-inferiority difference was set as − 10%.

Results

In the full analysis set, the primary endpoint of final efficacy rate was 81.3% (n = 91) in the LOX-T group and 72.2% (n = 88) in the LOX-O group. The difference between the two groups was 9.1% [95% confidence interval (CI) − 3.1 to 21.3%], which showed that LOX-T was non-inferior compared with LOX-O. No serious adverse events occurred in either group.

Conclusions

This trial showed the non-inferiority of LOX-T compared with LOX-O in efficacy and safety in Chinese patients with myalgia. Also, the characteristic features of topical LOX-T, such as better compliance and lower risk-benefit ratio, make it more favorable for clinical practice.

Trial Registration

The study was registered in the isrctn.com registry (ISRCTN trial ID: ISRCTN16227145).
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Metadata
Title
Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial
Authors
Dongbao Zhao
Zhiwei Chen
Shaoxian Hu
Jianhao Lin
Zengwu Shao
Guochun Wang
Weiguo Xiao
Yi Zheng
Zhiyi Zhang
Yeqing Shi
Zhanguo Li
Publication date
01-04-2019
Publisher
Springer International Publishing
Keywords
Myalgie
Myalgia
Published in
Clinical Drug Investigation / Issue 4/2019
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-019-00756-x

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