An observational study to evaluate the efficacy and safety of Mefenamic acid (Meftal-P Suspension) in children with febrile illness
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of Mefenamic Acid (MEFTAL-P Suspension) at the standardized dose of (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.
研究概览
简要总结
This clinical study to evaluate the efficacy and safety of Mefenamic Acid (Meftal-P Suspension) in Children with Febrile illness. Symptomatic treatment of fever in pediatric and adolescent subjects aged 6 months to <18 years.
A total of 50 subjects aged 6 months to <18 years with febrile illness will be enrolled and dose of 5mg/kg of body weight thrice a day for 3 days will be prescribed to be taken thrice daily, orally. Visit-2 will be on Day 3 and study related assessments will be performed. And Visit-3 (Day 7) will be the end of the study visit and all the relevant study related procedures will be performed as per the study protocol.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females aged 6 months to less than 18 years.
- •2.Subject diagnosed with febrile illness i.e., fever ranging between (100.5°F – 104°F).
- •3.Subject can consume oral medication.
- •4.Able to give oral/written assent/parental consent from a parent/guardian.
排除标准
- •1.Subjects who have used acetaminophen within 6 hours or ibuprofen, aspirin, or other NSAIDs within 8 hours prior to screening.
- •2.Subjects with Hypersensitivity to Mefenamic Acid or NSAIDs. 3.History of renal, hepatic impairment, diabetes mellitus, or thrombocytopenia.
- •4.Moderate or severe dehydration.
- •5.Severe underlying illness that contraindicates study participation (e.g., kidney disease, etc.).
结局指标
主要结局
1. To evaluate the efficacy of Mefenamic Acid (MEFTAL-P Suspension) at the standardized dose of (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.
时间窗: To measure the percentage reduction in fever from | baseline (Day 1) at three daily time points (morning, noon, and night) | over the 3-day treatment period. | Baseline (Day 1) to Day 3
2. To assess the safety and tolerability of standardized dosing of mefenamic acid (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.
时间窗: To measure the percentage reduction in fever from | baseline (Day 1) at three daily time points (morning, noon, and night) | over the 3-day treatment period. | Baseline (Day 1) to Day 3
次要结局
- To assess the safety profile, monitor adverse events, and(determine the time required to achieve sustained normothermia)
研究者
Dr Vanasnt M Khalatkar
Khalatkar Hospital