A multicentric, randomized, comparative clinical trial to evaluate the efficacy
and safety of S-etodolac in the treatment of osteoarthritis in Indian patients.
Author(s): Sancheti P, Hardikar M, Karne N, Panse J, Singh S, Maria A, Basu I.
Affiliation(s): Sancheti Institute for Orthopedics and Rehabilitation, Shivaji Nagar, Pune,
India. parag@sanchetihospital.org
Publication date & source: 2010, Int J Clin Pharmacol Ther. , 48(7):429-34
OBJECTIVE: To compare the efficacy and safety of S-etodolac with etodolac in the
treatment of osteoarthritis in Indian patients.
MATERIALS AND METHODS: This was a double-blind, multicentric, comparative
clinical trial conducted in 108 Indian patients with osteoarthritis. All patients
received either S-etodolac ER 300 mg or etodolac ER 600 mg tablets once daily.
Assessment was done on the basis of WOMAC score and VAS pain score, patient's and
physician's global assessment of the arthritic condition. All patients were
evaluated after every 2 weeks for 4 weeks for efficacy and safety variables.
RESULTS AND DISCUSSION: Total 49 patients in the test group and 52 patients in
the reference group completed the study. There was significant improvement (p <
0.0001) in all WOMAC subscales (pain, stiffness and physical function), WOMAC
total score and VAS pain score in both the groups. Patient's and physician's
global assessment of the arthritic condition also improved significantly (p <
0.0001). All patients showed improvement in WOMAC and VAS pain score by (3) 20%.
There was no significant difference between the groups for the efficacy
parameters. The adverse events reported were few and no serious adverse events
were reported. Total 5 patients in S-etodolac group and 2 patients in etodolac
group dropped out of the study. Only 1 patient dropped out because of the side
effects of burning sensation, palpitations and anxiety in the test group.
CONCLUSION: The present study has established the efficacy, tolerability and
safety of S-etodolac extended release tablets in the treatment of osteoarthritis
in Indian patients.
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