An Open-Label, Multicenter, Randomized, Parallel, Four-Arm, Interventional Study to Compare the Rapid Antipyretic and Analgesic Efficacy and Safety of Paracetamol Tablets in Adults with Acute Febrile or Febrile-Pain Conditions (THE FAST STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 4
研究概览
简要总结
After obtaining written approval from the Ethics Committees, eligible febrile adult male and female patients presenting with/ without associated pain will be enrolled. Details such as demographic data, medical history/comorbidities, and prior medications will be recorded at baseline before treatment. Vital signs including blood pressure, pulse rate, and respiratory rate will be recorded. Body temperature (oral) will be measured using a calibrated digital thermometer and noted. Participants will be asked to record their pain on the NRS scale. All eligible participants will receive a single dose of one of the four study medications (SUMO-L™ Fast 650, Dolo-650®, Calpol 650, and Paracetamol Tablets IP 650 mg (unbranded/generic label)) depending on randomization. Participants will thereafter be monitored in-person over the next 90±2 min. Recording of temperature and pain score will be done at 10±2, 15±2, 20±2, 30±2, 45±2, 60±2, and 90±2 min after single dose administration of study medication. Patient satisfaction will be recorded at 90±2 min based on resolution of febrile or febrile-pain conditions. AEs and SAEs will be recorded throughout study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 or female aged 18 to 60 years (both inclusive)
- •Body temperature (oral) greater than equal to 38 degree celsius (greater than equal to 100.4degree Fahrenheit), with or without associated pain
- •Willingness to provide written informed consent.
排除标准
- •Known allergy/ hypersensitivity/ contraindications to paracetamol/acetaminophen
- •Fever/pain caused due to chronic clinical conditions (e.g., osteoarthritis, tuberculosis, malignancy, etc.)
- •Known liver dysfunction, defined as raised alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or levels of ALT/ AST greater than 2 times the upper limit of normal (ULN) based on lab reports within 1 month prior to screening or as per Investigators judgement
- •Use of any antipyretic or analgesic within 12 hours prior to screening
- •Requirement of hospitalization at baseline
- •Pregnant or lactating women
- •Refusal or inability to comply with the requirements of the protocol for any reason, including stay at study site for data accrual till 90±2 min post single dose administration and answering questionnaires
- •Any other condition(s) in the individual which, in the opinion of the Investigator, could confound the results of the trial, put the patient at undue risk, or make the patient unsuitable for participation.
研究者
Dr Amitrajit Pal
Alkem Laboratories Ltd.