EUCTR2014-001863-11-SK进行中（未招募）不适用
A Phase 4, Randomised, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy of Isoprinosine® in Comparison With Placebo in Subjects With Confirmed Acute Respiratory Viral Infections due to Influenza A or B Virus, Respiratory Syncytial Virus, Adenovirus, or Parainfluenza Virus 1 or 3.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or nonpregnant female subjects aged 18 to 55 years.
- •Female subjects must be either surgically sterile, postmenopausal (no menses during the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, injectable or implanted hormonal contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence).
- •2. Has an influenza-like illness defined as:
- •oral temperature of =38°C obtained at study site. If oral temperature measured at screening is <38°C, then the subject will still be eligible if he or she has self-measured the oral temperature at home as =38°C within 12 hours prior to screening and have taken an antipyretic within 4 hours prior to screening
- •at least 1 of the following respiratory symptoms: cough, sore throat, or nasal obstruction that is considered by the subject to be moderate or severe in intensity (rated greater than mild” on a 4-point scale , and
- •at least 1 of the following constitutional symptoms: fatigue, headache, myalgia, or feverishness that is considered by the subject to be moderate or severe in intensity (rated greater than mild” on a 4-point scale ).
- •3.Has onset of influenza-like illness no more than 36 hours prior to screening, defined as when the subject experienced fever and at least 1 respiratory symptom and at least 1 constitutional symptom.
- •4.Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements, including completion of the subject diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 430
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Has immunosuppressive disorder or who is receiving immunosuppressive therapy (eg, immunosuppressants, antitumour agents).
- •2.Is receiving treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents, or treatment with thiazide diuretics (eg, hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (eg, furosemide, torsemide, and ethacrynic acid).
- •3.Has chronic renal dysfunction (creatinine clearance <50 mL/min).
- •4.Has liver disorder (severe liver function impairment; aspartate aminotransferase and alanine aminotransferase values greater than 3 times the upper limit of normal).
- •5.Is lactose intolerant.
- •6.Has cancer in a nonremission stage (subject with nonmetastatic basal cell or squamous cell skin cancer or other early cancer for which surgical resection is considered to be completely curative is eligible for enrolment).
- •7.Is a resident of a nursing home or other long-term care institution.
- •8.Is receiving treatment with zidovudine.
- •9.Is pregnant or lactating/breastfeeding female.
- •10.Has received any dose of Isoprinosine, oseltamivir, zanamivir, amantadine, or rimantadine during this period of influenza-like illness.
- •11.Has received prior treatment with any investigational drug or vaccine within 30 days prior to screening.
- •12.Has known hypersensitivity to inosine acedoben dimepranol or any of the excipients comprising Isoprinosine from the 500 mg Isoprinosine tablets.
- •13.Has a medical history of hyperuricaemia or gout.
- •14.Is unable to take oral medications.
- •15.Has any preexisting illness that, in the opinion of the investigator, would place the subject at an increased risk through participation in this study.
- •16.Is a subject who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
研究者
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