Prospective real world study comparing the safety and effectiveness of Nimesulide with available anti-pyretic and analgesics for treatment of fever or fever with pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 5
- 主要终点
- - Reduction in fever - Body temperature will be evaluated at timepoints.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
- Reduction in fever - Body temperature will be evaluated at timepoints.
时间窗: 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.
时间窗: 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
次要结局
- - 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.)