Drug Trial: Study

Osteoarthritis (OA) is a disease that affects knee joint most commonly, as the age progresses after fourth decade of life. The surface within joints become damaged so the joint doesn’t move as smoothly as it should. OA is usually diagnosed based on clinical signs and symptoms when examining joints.

Occurring most frequent in the knee, the prevalence of OA in this joint increases with age from approximately 1% in people aged 25-34 years to >30% in people aged > 75years. NSAID’s are commonly used for the management of OA and are effective in relieving the pain and physical dysfunction. NSAID’s are used to treat pain, swelling and inflammation from medical conditions such as OA.

NSAID’s may increase the chance of heart attack or stroke that can lead to death. This chance increases with longer use of NSAID’s in people who have heart disease. However , their use is associated with GI effects, ranging from mild heartburn and bloating to serious ulceration, perforation, obstruction, and bleeding, and with hepatic and renal toxic effects.

Subjects with OA whose symptoms are not adequately controlled with conventional or oral NSAID’s may require topical NSAID’s. International guidelines on OA care recommend the use of topical NSAID’s as an alternative to oral NSAID’s. Also , the OA research society international guidelines recommended topical NSAID’s as a first line therapy for subjects with OA and it was observed that the topical NSAID’s had an equivalent efficacy and a lower frequency of adverse events compared with oral NSAID’s.

Diclofenac is a NSAID, which works by reducing hormones that cause inflammation and pain in the body. The study medication in the present study is a gel formulation that contains the diclofenac sodium as its active ingredient. Various studies have reported diclfenac sodium gel to be safe and effective in subjects of OA of the knee.

In our department we had conducted drug trial under the heading “A Prospective , Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Bioequuivalance Study With Clinical Endpoints Comparing Generic Diclofenac Sodium Topical Gel 1% of Cipla Ltd., India To Voltaren Gel (A Diclofenac Sodium Topical Gel 1%) Of Endo Pharmaceutical Inc., USA In Subjects With Osteoarthritis Of The Knee” from March 2016 To February 2017, under the Guidance of Dr. Sanjay Patil (Head of the department in orthopaedics, Bharati Hospital) and Dr. Gopal Pundkare (Assistant Professor in department of orthopaedics, Bharati Hospital)