title: A multicentric, randomized, comparative clinical trial to evaluate the efficacy and safety of S-etodolac in the treatment of osteoarthritis in Indian patients.
abstract: OBJECTIVE
  To compare the efficacy and safety of S-etodolac with etodolac in the treatment of osteoarthritis in Indian patients.
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  The present study has established the efficacy, tolerability and safety of S-etodolac extended release tablets in the treatment of osteoarthritis in Indian patients.
authors.affiliation: Sancheti Institute for Orthopedics and Rehabilitation, Shivaji Nagar, Pune, India. parag@sanchetihospital.org
authors.forename: P
authors.initials: P
authors.lastname: Sancheti
authors.forename: M
authors.initials: M
authors.lastname: Hardikar
authors.forename: N
authors.initials: N
authors.lastname: Karne
authors.forename: J
authors.initials: J
authors.lastname: Panse
authors.forename: S
authors.initials: S
authors.lastname: Singh
authors.forename: A
authors.initials: A
authors.lastname: Maria
authors.forename: I
authors.initials: I
authors.lastname: Basu
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004311:Double-Blind Method; D017308:Etodolac / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010147:Pain Measurement
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D017308:Etodolac