A phase III trial evaluating the efficacy and tolerability of nimesulide 1% spray in patients with soft-tissue injuries
Mazharuddin Ali Khan1, Madhusudhan Rao2, Madan M Reddy3, Datta Tamloorker4, Vishesh Gumdal5, Moodahadu S Latha6, Binny Krishnankutty7
1 Department of Orthopedics, Deccan College of Medical Sciences, Hyderabad, India
2 Department of Orthopedics, Mediciti Hospital, Hyderabad, India
3 Department of Orthopedics, Apollo Hospitals, Chennai, India
4 Department of Orthopedics, Dr. V R K Hospital, Hyderabad, India
5 Department of Rheumatology, GVN Medical Centre, Hyderabad, India
6 Global Medical Affairs, Dr. Reddy's Laboratories, Hyderabad, India
7 Department of Pharmacology, Azeezia Medical College, Kollam, India
Mazharuddin Ali Khan
Department of Orthopedics, Deccan College of Medical Sciences, Kanchanbagh, Hyderabad
Source of Support: Study was sponsored by Dr. Reddy’s Laboratories Hyderabad, India, Conflict of Interest: Dr. M S Latha, and Dr. Binny, Krishnan Kutty are the employees of Dr. Reddy’s Laboratories Ltd., which is manufacturing Nimesulide spray in India. These authors are stakeholders having financial stakes in Dr. Reddy’s Laboratories Ltd. by means of salary, company stocks or both. Dr. Mazharuddin Ali Khan, Dr. Madhusudhan Rao, Dr. Madan Mohan Reddy, Dr. Dutta Tamloorker and Dr. Vishesh G. do not have any conflict of interest
Aim: To evaluate the efficacy and safety of nimesulide 1% w/w spray in minor soft-tissue injuries in adult Indians through a multicentric, open-labeled, phase III trial.
Materials and Methods: 125 eligible patients, who met the selection criteria and gave written informed consent, were screened, enrolled, and treated with nimesulide 1% spray for seven days. Patients were assessed at baseline, day 1, day 4, and day 8 for efficacy and safety. Primary efficacy variable pain intensity, was measured using a NRS 1-100 mm (numerical rating scale). Secondary efficacy variables were degree of inflammation and edema and degree of functional impairment; overall assessment of efficacy was done by patient (patient global assessment - PGA) and by investigator (investigator global assessment - IGA) on days 4 and 8.
Result: There was a statistically significant reduction in the NRS score, degree of pain, edema (inflammation), and improvement in functional impairment on days 4 and 8 and in serum creatine kinase levels on day 8 in comparison with baseline. Global assessment of efficacy on day 8 was rated as "very good (21%)," "good (67.70%)," and "fair (11.30%)" by investigators and "very good (25%)," "good (58.90%)," and "fair (16.1%)" by patients. Two mild adverse events were reported in two patients, which resolved without any intervention. One (local irritation) was reported as not related, while the other (itching sensation) was probably related to the study drug.
Conclusion: Nimesulide 1% spray was effective with a good safety profile and can be considered is a good alternative to oral analgesic therapy in minor soft-tissue injuries.