title: Efficacy and safety of aceclofenac-cr and aceclofenac in the treatment of knee osteoarthritis: a 6-week, comparative, randomized, multicentric, double-blind study.
abstract: The efficacy and safety of aceclofenac control release (CR) tablets was compared with conventional aceclofenac tablets in patients with knee osteoarthritis (OA). This was a double-blind, double-dummy, randomized, parallel group multicentric study conducted at 6 centers. Two hundred and eighty five patients were randomized to either aceclofenac-CR (n = 143) once daily or conventional aceclofenac tablet (n = 142) twice daily and were followed for 6 weeks. The efficacy parameters were pain intensity score on visual analogue scale, Western Ontario and McMaster (WOMAC) score, patients and investigator's overall study drug assessment and total consumption of acetaminophen and ranitidine tablets. Both treatments showed significant improvement in their efficacy parameters from baseline at the end of therapy. Aceclofenac-CR was comparable to conventional aceclofenac with respect to change in pain intensity and WOMAC score (P > .05) There was no statistically significant difference between the treatment groups in patient's and investigator's overall study drug assessment at the end of therapy (P > .05). Aceclofenac-CR treated patients took fewer acetaminophen and ranitidine tablets during the treatment period as compared to conventional aceclofenac treated patients. Both the study medications were well tolerated with no incidence of serious adverse event (SAE). In conclusion, the new aceclofenac-CR formulation was found to be effective and safe while offering practical advantage of once daily administration.
  
  
  CONCLUSIONS
  This article represents the advantages of control release aceclofenac over the conventional aceclofenac tablets. Aceclofenac-CR was found to be similar in terms of efficacy as conventional aceclofenac in knee OA patients with fewer adverse events.
authors.affiliation: Medical Affairs and Clinical Research, Ipca Laboratories Limited, Mumbai, India. anilpareek@ipca.co.in
authors.forename: Anil
authors.initials: A
authors.lastname: Pareek
authors.forename: Nitin
authors.initials: N
authors.lastname: Chandurkar
authors.forename: Anil
authors.initials: A
authors.lastname: Gupta
authors.forename: Ashish
authors.initials: A
authors.lastname: Sirsikar
authors.forename: Bhavik
authors.initials: B
authors.lastname: Dalal
authors.forename: Bhavesh
authors.initials: B
authors.lastname: Jesalpura
authors.forename: Anoop
authors.initials: A
authors.lastname: Mehrotra
authors.forename: Arunangshu
authors.initials: A
authors.lastname: Mukherjee
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D004008:Diclofenac; C056498:aceclofenac