Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain

BMC Musculoskeletal Disorders

Research

Junfei Zhang¹  Peter Zeng¹  Tracy Lu¹  Frédérique Bariguian Revel²  Mako Araga³  Shiva Patel³  Sebastian Moreira³  Weibin Zhang⁴  Feng Yin⁵  Haijun Xiao⁶  Jinzhong Ma⁷  Rongguang Ao⁸  Wei Wang⁹  Wencui Li^1,10  Fengqi Zhang^1,11 

[1] GSK China Consumer Healthcare, Shanghai, China;GSK Consumer Healthcare SARL, Nyon, Switzerland;GSK Consumer Healthcare, Warren, NJ, USA;Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China;Shanghai East Hospital, Shanghai, China;Shanghai Fengxian Central Hospital, Shanghai, China;Shanghai General Hospital, Shanghai, China;Shanghai Pudong Hospital, Shanghai, China;Shenyang Orthopedic Hospital, Shenyang, China;Shenzhen Second People’s Hospital, Shenzhen, China;The Third Hospital of Hebei Medical University, Shijiazhuang, China;

关键词: Diclofenac diethylamine gel;    Ankle injury;    Sprain;    Analogue pain scale;   

DOI  :  10.1186/s12891-022-06077-z

 received in 2022-04-29, accepted in 2022-12-09,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundDiclofenac diethylamine (DDEA) gel has demonstrated efficacy for treatment of ankle sprains in both the 1.16% four-times-daily (QID) and 2.32% twice-daily (BID) formulations. The objective of this study was to compare, for the first time, the efficacy of DDEA 2.32% gel BID and DDEA 1.16% gel QID.MethodsThis was a phase 3, randomized, double-blind, multicenter, active-controlled, parallel-group study conducted in China from October 2019 to November 2020, designed to determine the noninferiority of DDEA 2.32% gel BID relative to DDEA 1.16% gel QID for treatment of grade I–II ankle sprain. At study entry, patients must have had pain on movement (POM) ≥50 mm on a 100-mm visual analogue scale (VAS), and not received any pain medication. The primary efficacy endpoint was the noninferiority of DDEA 2.32% gel BID vs DDEA 1.16% gel QID for POM as assessed by the patient using the 100-mm VAS, conducted on day 5. Secondary endpoints included measures of ankle tenderness, joint function, swelling, and patient-reported pain intensity and pain relief.ResultsA total of 302 patients were randomized and 95.4% completed the study. The mean (SD) change in POM from baseline to day 5 using the 100-mm VAS was − 42.8 mm (19.7 mm) with DDEA 2.32% gel BID and − 43.1 mm (18.1 mm) with DDEA 1.16% gel QID for the per-protocol population. The least squares mean difference (DDEA gel 2.32% – DDEA gel 1.16%) at this timepoint was 1.11 mm (95% CI − 3.00, 5.22; P = 0.595), and the upper limit (5.22 mm) of the 95% CI was less than the noninferiority margin of 13 mm, demonstrating that DDEA 2.32% gel BID was noninferior to DDEA 1.16% gel QID. Similar trends were seen for the secondary efficacy endpoints. There was no significant difference in the incidence of treatment-emergent adverse events or adverse events adjudicated as being treatment related. All treatment-related adverse events were dermatological; one patient discontinued from the DDEA 2.32% gel BID arm due to application-site inflammation.ConclusionsDDEA 2.32% gel BID offers a convenient alternative to DDEA 1.16% gel QID, with similar pain reduction and relief, anti-inflammatory effects, and tolerability.Trial registrationNCT04052620.

【 授权许可】

CC BY   
© The Author(s) 2022

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