An observational study to determine safety and efficacy of Nimesulide versus available treatment for fever and pain management.
- Conditions
- Fever, unspecified,
- Registration Number
- CTRI/2023/10/058936
- Lead Sponsor
- Dr. Reddy’s Laboratories Ltd
- Brief Summary
This is a prospective, multi-center, comparative, observational study to assess the safety and efficacy of Nimesulide 100 mg tablets versus Ibuprofen plus Paracetamol, and Paracetamol. This study will be conducted at or up to five study sites in India. In this study, real world data generated will be compared to evaluate the safety and effectiveness of Nimesulide, Ibuprofen plus Paracetamol and Paracetamol alone in adult patients with fever or fever with pain. Patients will be divided into three groups based on study drug prescribed by the investigator. Total 303 patients will be enrolled in the study. Patients will be grouped as below:
Group 1- Nimesulide 100mg tablets (N=101)
Group 2- Ibuprofen (400mg) plus Paracetamol (325mg) (N=101)
Group 3- Paracetamol (650mg) (N=101)
In this study, Nimesulide will be compared with Ibuprofen plus Paracetamol and Paracetamol alone by observing reduction in fever from 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours post consuming study drug by the patient and on Day 1 and thereafter once every day till recovery i.e. EOT maximum up to Day 10 using a thermometer; and by observing reduction in pain intensity via self-reported Visual Analogue Scale (VAS) provided by investigator from baseline to 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours, post dosing and on Day 1 and thereafter once every day till EOT maximum up to Day 10. Efficacy will be assessed under Full Analysis Set (FAS) and PP (per protocol) set.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 303
- Male and female patients of age between 18 to 60 years (both inclusive) and who have been recommended either Nimesulide or Ibuprofen plus Paracetamol or Paracetamol alone during their routine clinic visit at the discretion of the investigator.
- Patients who are able to understand written and or verbal instructions and are ready to comply with all study requirements with a willingness to participate and ready to give written informed consent voluntarily.
- Contraindications to study medication as per approved label in the country.
- Patients who are not fit for the study as per the investigator’s discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Reduction in fever - Body temperature will be evaluated at timepoints. Fever and pain | - Day 0 (0 min, 15 min, 30 min, 1 Hour, 2hour, 4 hour and 6 hour) | - Day 1 thereafter once every day till recovery i.e. | - EOT maximum up to Day 10 - Reduction in pain - Pain intensity will be evaluated by using self-reported Visual Analogue Scale (VAS) score at timepoints. Fever and pain | - Day 0 (0 min, 15 min, 30 min, 1 Hour, 2hour, 4 hour and 6 hour) | - Day 1 thereafter once every day till recovery i.e. | - EOT maximum up to Day 10
- Secondary Outcome Measures
Name Time Method - Patient reported side effects, adverse drug reactions and adverse events of special interest (AESI) like hepatic and renal adverse events will be assessed. - Vital parameters like blood pressure [mm Hg], pulse rate [beats per minute], respiratory rate [breaths per minute] and physical examination will be assessed as additional safety parameters.
Trial Locations
- Locations (5)
Dr. Mustafas clinic, Hyderabad
🇮🇳Hyderabad, TELANGANA, India
Maharaja Agrasen Hospital
🇮🇳Delhi, DELHI, India
Medipoint Hospitals, Pune
🇮🇳Pune, MAHARASHTRA, India
Medstar Multispeciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Ojas Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr. Mustafas clinic, Hyderabad🇮🇳Hyderabad, TELANGANA, IndiaDr Syed Mustafa AshrafPrincipal investigator91-9177629541asrarhoo@gmail.com