NCT04043923已完成2 期
A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 17
- 主要终点
- Time to alleviation of symptoms
研究概览
简要总结
This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
- •Symptoms of ILI including all of the following:
- •Fever ≥38º Celsius (oral) in the predose examinations or >4 hours after dosing of antipyretics if they were taken
- •At least one of the following general systemic symptoms associated with ILI are present with a severity of moderate or greater: headache, feverishness or chills, muscle or joint pain, fatigue
- •At least one of the following respiratory symptoms associated with ILI are present with a severity of moderate or greater: cough, sore throat, nasal congestion
- •The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:
- •Time of the first increase in body temperature (an increase of at least 1º Celsius from normal body temperature)
- •Time when the subject experiences at least one general or respiratory symptom
- •Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
排除标准
- •Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
- •Severe ILI requiring inpatient treatment
- •Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):
- •Residents of nursing homes or other long-term care facilities
- •American Indians and Alaska natives
- •Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
- •Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
- •Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
- •Blood disorders (such as sickle cell disease)
- •Endocrine disorders (such as diabetes mellitus)
- •Kidney disorders
- •Liver disorders
- •Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- •Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)
- •Extreme obesity (body mass index ≥40 kg/m^2)
- •Presence of any severe or uncontrolled medical or psychiatric illness
- •History of or current autoimmune disease
- •History of recurrent lower respiratory tract infection
- •Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
- •Female subjects who are pregnant or breastfeeding
- •Any clinically significant electrocardiogram test
- •Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
- •Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
- •Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
- •Exposure to an investigational drug within 30 days prior to the pre-dose examinations
- •History of allergic reaction to ketotifen
- •Any prior exposure to norketotifen
研究组 & 干预措施
Norketotifen
Experimental
Norketotifen oral capsules, once daily for 5 days
干预措施: Norketotifen (Drug)
Placebo
Placebo Comparator
Placebo oral capsules, once daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time to alleviation of symptoms
时间窗: 14 days
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
次要结局
- Proportion of subjects whose symptoms have been alleviated at each time point through Day 5(5 days)
- Change from baseline in composite symptom score at each time point through Day 5(5 days)
- Time to resolution of fever (body temperature equal to or less than 37ºC)(14 days)
- Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)(14 days)
- Time to resumption of normal activity(14 days)
- Body temperature at each time point through Day 5(5 days)
- Use of rescue medication (acetaminophen)(14 days)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like IllnessInfluenzaInfluenza -Like IllnessNCT04610047Emergo Therapeutics, Inc.315
已完成
2 期
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult WomenOveractive BladderNCT03475706Velicept Therapeutics, Inc.438
已完成
2 期
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)Overactive BladderNCT03594058Velicept Therapeutics, Inc.1,413
已完成
2 期
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber NeuropathySmall Fiber NeuropathyNCT03304522Vertex Pharmaceuticals Incorporated89
终止
2 期
Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus InfectionHCV InfectionNCT00874796Gilead Sciences307