CTRI/2011/03/001653已完成4 期
An open label, randomized, controlled multicentre study to assess the effectiveness and tolerability of Para IR (Panacea Biotec Ltd, India) in comparison to Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with Fever
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- To compare the effectiveness of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) for faster relief of Fever
研究概览
简要总结
Panacea Biotec Ltd has developed a formulation of Paracetamol (Para IR) which is Immediate Release. This is expected to relieve the fever faster then the existing Paracetamol formulations. To show the superior effectiveness of product Para IR for faster relief of fever it has been planned to compare with one of the most commonly used formulation of Paracetamol i.e. Calpol tablets of GlaxoSmithKline Pharmaceutical Ltd.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex, 18-65years 2.Patients having fever at least 380C or 100.40F 3.Patients willing to give informed consent 4.Patients able to take oral medications.
排除标准
- •1.Subjects requiring hospitalization 2.Subjects with known or suspected hypersensitivity to paracetamol or any the constituents of the formulation.
- •3.Subjects who have received any other investigational drug within 1 month prior to screening or enrollment.
- •4.Subjects who have received Paracetamol or any NSAID within 6 hours prior to enrollment.
- •5.Subjects who are receiving other medications or who have disease conditions that could interfere with the evaluation of drug efficacy or drug safety.
结局指标
主要结局
To compare the effectiveness of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) for faster relief of Fever
时间窗: One and half Hour
次要结局
- To compare the tolerability of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with Fever(One and half Hour)
研究者
研究点 (3)
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