CTRI/2018/10/016216尚未招募3 期
A single center open-label non-comparative single-dose pilot clinical study evaluating efficacy and safety of standard intramuscular preparation of Paracetamol available in the market for the management of fever
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1 Proportion of completed patients achieving target oral temperature
研究概览
简要总结
The usual dose in adults is 500 mg to 1 gm per administration that can be given in 4 doses (maximum dosage 4 gm/day). However, an intramuscular formulation delivering 500 mg of paracetamol is currently not approved/available, making dosing very inconvenient. This study is planned as a pilot study as instructed by the DCG(I), in the process of evaluation of parent 500 mg delivering formulation developed by Troikaa Pharmaceuticals Limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 Having fever oral temperature between 101 to 104 F both inclusive of recent onset more than 3 days and expected to be hospitalized more than 24 hrs 2 Willing to comply with study requirements including periodic measurements or examinations laboratory investigations and avoiding any intramuscular administration during the entire study duration of 7 days as documented by provision of written Informed Consent prior to participation in the study.
排除标准
- •1 Fever suspected to be due to neurological infection or any cancer 2 Patient receiving any IM injection for the co morbid condition and where the IM injection are expected to continue 3 High grade fever more than 104 F or suspected septicemia 4 Hypotension inferred from systolic blood pressure more than 90 mmHg 5 Admission in intensive care unit or intensive cardiac care unit 6 Severe kidney creatinine more than 2 mg per dl or liver disease SGOT and SGPT more than 3 times ULN and based on discretion of the investigator 7 Patients with serum CPK levels more than 5 times the ULN for that gender.
结局指标
主要结局
1 Proportion of completed patients achieving target oral temperature
时间窗: 180 ± 15 minutes after study drug administration or before
次要结局
- 1 Mean reduction in oral temperature at each time point compared to(baseline)
研究者
研究点 (1)
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