An observational study to determine safety and efficacy of Nimesulide versus available treatment for fever and pain management.
Not Applicable
Completed
- Conditions
- Health Condition 1: R509- Fever, unspecified
- Registration Number
- CTRI/2023/10/058936
- Lead Sponsor
- Dr. Reddy’s Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 303
Inclusion Criteria
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.
Exclusion Criteria
- 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. <br/ ><br>- Reduction in pain - Pain intensity will be evaluated by using self-reported Visual Analogue Scale (VAS) score at timepoints.Timepoint: Fever and pain <br/ ><br>- Day 0 (0 min, 15 min, 30 min, 1 Hour, 2hour, 4 hour and 6 hour) <br/ ><br>- Day 1 thereafter once every day till recovery i.e. <br/ ><br>- 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. <br/ ><br>- 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.Timepoint: - Day 0 <br/ ><br>- Day 1, till recovery <br/ ><br>- EOT maximum up to Day 10