Evaluation of efficacy and safety of a novel lipogel containing diclofenac: A randomized, placebo controlled, double-blind clinical trial in patients with signs and symptoms of osteoarthritis

Amit Bhatia; Vijay Goni; Shruti Chopra; Bhupinder Singh; Om Prakash Katare

doi:10.1016/j.conctc.2020.100664

Evaluation of efficacy and safety of a novel lipogel containing diclofenac: A randomized, placebo controlled, double-blind clinical trial in patients with signs and symptoms of osteoarthritis

Contemp Clin Trials Commun. 2020 Oct 7:20:100664. doi: 10.1016/j.conctc.2020.100664. eCollection 2020 Dec.

Authors

Amit Bhatia^{1

2

3}, Vijay Goni⁴, Shruti Chopra², Bhupinder Singh³, Om Prakash Katare³

Affiliations

¹ Department of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University, Badal Road, Bathinda, Punjab, 151 001, India.
² Amity Institute of Pharmacy, Amity University, Sector 125, Noida, Uttar Pradesh, 201 303, India.
³ University Institute of Pharmaceutical Sciences, Panjab University, Sector 14, Chandigarh, 160 014, India.
⁴ Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160 012, India.

Abstract

Background: Effectiveness and safety of pharmaceuticals is the prime concern of every osteoarthritis (OA) treatment. Chronic administration of NSAIDs, especially in case of geriatrics, through oral route tend to compromise the patient's safety, whereas topical treatments are not found to be effective owing their poor ability to deliver drug molecules.Thus, the present study deals with a randomized, double-blind, controlled trial conducted on patients with knee osteoarthritis (OA) for comparing the performance of a novel topical gel (liposomal gel) of diclofenac with a placebo and a marketed gel.

Methods: The patients were treated and evaluated for 6 weeks as per the Western Ontario McMaster Universities (WOMAC) Index for OA. Patients were also observed for any adverse events. All the results were analyzed statistically using Kruskal-Wallis test, followed by Student's t-test at p ≤ 0.05.

Results: Patients treated with liposomal gel showed statistically significantly improvements in treatment in comparison to the other tested formulations. All the treatments were found to be well tolerated with no report of adverse event. The results unequivocally demonstrated the superiority of the diclofenac liposomal gel, in the relieving the symptoms of OA of the knee, in comparison to placebo and marketed gel.

Conclusion: From above results it was revealed that the drug in liposome have higher therapeutic potential. Thus, this can be a safe and effective option for the management of chronic OA especially for geriatric patients.

Keywords: Efficacy; Liposome; Nanomedicine; Osteoarthritis; Patient compliance; Topical drug delivery.