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Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial
Villegas-Rivera Geannyne1*, Covarrubias-Pinedo Amador1, Romero-Medina Silvia2, Solorza-Camacho Karim Saul2, Alatorre-Carranza María del Pilar1, Rodríguez-Herrera Lourdes Yolotzin1, Jaime Islas-Nilssa Graciela1 and Galaviz-Muro Adriana11Instituto de Investigación Clínica de Occidente, Clinical Research, Mexico
- *Corresponding Author:
- Geannyne VR
Instituto de Investigación Clínica de Occidente, Clinical Research
5674 Ludwig Van Beethoven Street, Zapopan, Jalisco, 45030, México
Tel: +52 (01) 33 36298485
E-mail: gvillegas.md@gmail.com
Received date: January 25, 2017; Accepted date: February 17, 2017; Published date: February 24, 2017
Citation: Geannyne VR, Amador CP, Silvia RM, Karim Saul SC, María del Pilar AC, et al. (2017) Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial. Clin Res Foot Ankle 5:226. doi:10.4172/2329-910X.1000226
Copyright: © 2017 Geannyne VR, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Objective: The aim of the study was to evaluate the efficacy of pain reduction and tolerability of topical administration of Celecoxib 2% cream compared to Celecoxib 1% cream and placebo cream in Mexican patients who had acute soft tissue injury in lower limbs.
Methods: A randomized, double-blind, placebo control trial with 3 parallel groups was conducted. We include Mexicans patients older than 18 years with diagnosis of acute soft tissue injury in lower limbs. They were randomly assigned to Celecoxib 2% cream (CEL-2), Celecoxib 1% cream (CEL-1) or placebo cream (PLA). All treatments should be applied 3 times a day for a period of 7 days. Every day the pain was assessed with a Visual Analogue Scale (VAS). Secondary, we evaluate inflammation and adverse events.
Results: A total of 95 patients were included. VAS on day 1 and 7 in group CEL-2 were 57.41 ± 10.39 mm and 4.34 ± 7.02 mm, in CEL-1 59.38 ± 9.37 mm and 10.41 ± 12.78 mm, and in PLA 55.61 ± 8.09 mm and 9.32 ± 9.93 mm. CEL-2 showed greater pain decrease compared to CEL-1 and PLA, p<0.05. CEL-1 group significantly decreased inflammation more than PLA, p<0.05. 15 adverse events were reported in 9 patients, none was severe.
Conclusion: The results shown in the present study demonstrate that topical administration of Celecoxib cream 2%, TID for 7 days was effective in pain relief in patients with acute soft tissue injury.
