title: Zaltoprofen, a noninferior alternative to diclofenac for the treatment of primary knee osteoarthritis -- a comparative evaluation of efficacy and safety in a 4-week, multicentric, randomized, double-blind, double-dummy trial.
abstract: OBJECTIVE
  To demonstrate the clinical noninferiority of the analgesic effect of zaltoprofen (80 mg t.i.d.) compared with diclofenac (50 mg t.i.d.) in active knee osteoarthritis patients.
  
  
  METHODS
  In this multicentric, double-blind, double-dummy, randomized, parallel-group, comparative study, 213 patients of either sex, aged 40 - 65 years having radiological and clinically confirmed primary knee osteoarthritis were randomized either to zaltoprofen (n = 105) or diclofenac (n = 108) and were followed-up at weeks 1, 2, 3 and 4. The treatment period was preceded by a washout period of 1 week.
  
  
  RESULTS
  Patients in both the zaltoprofen and diclofenac groups exhibited significant improvement (p < 0.001) in pain intensity, functional status and pain relief at each visit from baseline with no statistically significant difference between the two treatment groups. There was no statistically significant difference between the treatment groups for global assessment rating done by the patient and investigator at the end of therapy (p > 0.05) and the proportion of patients who consumed ranitidine (p = 0.135) and paracetamol (p = 0.086) tablets during the treatment period on both the treatment arms. Both the study medications were well tolerated with no incidence of serious adverse events.
  
  
  CONCLUSIONS
  This study demonstrated that efficacy and safety of zaltoprofen is clinically noninferior to that of diclofenac.
authors.affiliation: Medical Affairs and Clinical Research, Ipca Laboratories Ltd, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. anilpareek@ipca.co.in
authors.forename: Anil
authors.initials: A
authors.lastname: Pareek
authors.forename: Anil K
authors.initials: AK
authors.lastname: Gupta
authors.forename: Nitin B
authors.initials: NB
authors.lastname: Chandurkar
authors.forename: Ashish D
authors.initials: AD
authors.lastname: Sirsikar
authors.forename: Ratnakar E
authors.initials: RE
authors.lastname: Ambade
authors.forename: Bhavesh H
authors.initials: BH
authors.lastname: Jesalpura
authors.forename: Amit P
authors.initials: AP
authors.lastname: Swamy
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use*; D001578:Benzopyrans / Q000009:adverse effects* / Q000627:therapeutic use*; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007717:Knee / Q000473:pathology; D007719:Knee Joint / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D011422:Propionates / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001578:Benzopyrans; D010919:Placebos; D011422:Propionates; D004008:Diclofenac; C043940:pyranoprofen