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
May 2011, Vol. 12, No. 7
,
Pages 1007-1015
(doi:10.1517/14656566.2011.566867)
Anil Pareek †1 MD, Anil K Gupta4 MS, Nitin B Chandurkar2 MPharm, Ashish D Sirsikar3 MS, Ratnakar E Ambade6 MS, Bhavesh H Jesalpura7 MS & Amit P Swamy5 MS
1Medical Affairs and Clinical Research, Ipca Laboratories Ltd, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India +91 22 6647 4641; +91 22 2868 6954; anilpareek@ipca.co.in
2Clinical Research and Development, Ipca Laboratories Ltd, 48 International House, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India
3GR Medical College & JA Group of Hospitals, Department of Orthopedics, Gwalior 474009, India
4Mahatma Gandhi Medical College & Hospital, Department of Orthopedics, Sitapura, Jaipur 302022, India
5Padmashree Dr DY Patil Medical College, Department of Orthopedics, Sant Tukaram Nagar, Pimpri, Pune 411018, India
6Indira Gandhi Government Medical College & Mayo Hospital, Department of Orthopedics, Nagpur 440018, India
7Sheth VS Hospital, Department of Orthopedics, Ahmedabad 380006, India
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.
Method: 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.
