Evidence map›Paper›PMID 24924603›Full record

Trial reportClinical rheumatology2016

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial.

Rong Mu, Chun-de Bao, Zhi-wei Chen, Yi Zheng, Guo-chun Wang, Dong-bao Zhao, Shao-xian Hu, Yu-jun Li, Zeng-wu Shao, Zhi-yi Zhang and 3 more

Open access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Population Pharmacokinetics of Loxoprofen and its alcoholic metabolites in healthy Korean men.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Loxoprofen: A Review in Pain and Inflammation.Clinical drug investigation · 2016
    Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 2 countries.

Rong MuDepartment of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China. murongster@gmail.com.
Chun-de BaoDepartment of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. baochunde_1678@126.com.
Zhi-wei ChenDepartment of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China. czw0512@126.com.
Yi ZhengDepartment of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. zzyy90@sina.com.
Guo-chun WangDepartment of Rheumatology, China-Japan Friendship Hospital, Beijing, China. guochunwang@hotmail.com.
Dong-bao ZhaoDepartment of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China. dongbaozhao@163.com.
Shao-xian HuDepartment of Rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. sxianhu@139.com.
Yu-jun LiDepartment of Orthopaedics, Beijing Jishuitan Hospital, Beijing, China. liyujunmd@aliyun.com.
Zeng-wu ShaoDepartment of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. szwjj@medmail.com.cn.
Zhi-yi ZhangDepartment of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. zhangzhiyi@medmail.com.cn.
Wei-guo XiaoDepartment of Rheumatology, The First Hospital of China Medical University, Shenyang, China. xonet5670@163.com.
Weiya ZhangAcademic Rheumatology, University of Nottingham, Nottingham, NG5 1PB, UK. weiya.zhang@nottingham.ac.uk.
Zhan-guo LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China. lzg20140310@163.com.
Peking University · CNBeijing Chao-Yang Hospital · CNChanghai Hospital · CNChina-Japan Friendship Hospital · CNChina Medical University · CNFirst Affiliated Hospital of Harbin Medical University · CNHuazhong University of Science and Technology · CNPeking University People's Hospital · CNShanghai Jiao Tong University · CNSoochow University · CNUniversity of Nottingham · GBWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50%, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25% from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80% and significance level of 2.5% with a non-inferiority margin of -10%. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6% [95% confidence interval, -1.7 to 26.9%]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.

Indexed as

TabletsTransdermal PatchAgedAnti-Inflammatory Agents, Non-SteroidalChinaComorbidityDouble-Blind MethodFemaleHumansHydrogel, Polyethylene Glycol DimethacrylateMaleMiddle AgedOsteoarthritis, KneePain MeasurementPhenylpropionatesTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalHydrogel, Polyethylene Glycol DimethacrylateloxoprofenPhenylpropionatesTabletsHydrogel patchKnee osteoarthritisLoxoprofen sodiumTopical application

Identifiers

PMID24924603
OpenAlexW2056120683

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.