Abstracts Posters SICOT-SOF meeting Gothenburg 2010 _2_

Poster
Topic: General Orthopaedics
Abstract number: 24191
NOVEL FLEXIBLE-LIPOSOMAL GEL OF DICLOFENAC FOR PROLONGED AND
FASTER RELIEF: A RANDOMIZED, DOUBLE-BLIND CLINICAL STUDY.
Vijay GONI 1 , RAJ NIRMAL 2 , Amit BHATIA 3 , Pebam SUDESH 1 , Basant AMARJI 3 ,
Tajir TAMUK 1 , Ashish TANEJA 1 , Naveen TAHASILDAR 1 , Vel RAJAN SHAKTHI 1 ,
Bhupinder SINGH 3 , O.P KATARE 3
1 Post Graduate Institute of Medical Education and Research, Chandigarh (INDIA),
2 Chennai Medical College Hospital and Research Centre, Trichy (INDIA), 3 University
Institute of Pharmaceutical Sciences - UGC Centre For Advance Study Panjab
University, Chandigarh (INDIA)
To evaluate the efficacy of topically applied diclofenac in flexible-liposomal gel with a
marketed gel and placebo for relief of signs and symptoms in knee osteoarthritis
(OA).This was a randomized, double-blind, controlled trial on 30 patients with knee
osteoarthritis. They were randomly assigned to flexible-liposomal formulation, active
marketed formulation and placebo, three times a day for a period of 6 weeks. The
patients were assessed by primary efficacy outcome measures included the changes
from baseline to end of study on the WOMAC (Western Ontario McMaster
Universities) Osteoarthritis Index. The radiographic grading of OA in the knee was
performed by using the Kellgren-Lawrence criteria. We also assessed the safety by
evaluation of adverse events, vital signs, and irritation at the application site. The
pain, stiffness and difficulty performing routine activities showed statistically
significantly decrease on completion of 6 weeks treatment, in patient treated with
flexible-liposomal gel, compared to the other tested formulations. All the treatments
were found to be well tolerated with no adverse event. Diclofenac in flexibleliposomal
gel was found to be superior to other tested formulations like marketed gel
and placebo in the relieving the symptoms of OA of the knee. Hence, it can be
concluded that diclofenac in flexible-liposomal gel can be explored as a rational
alternative to oral diclofenac formulations for management of various pain and
inflammation related ailments including osteoarthritis.
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