CTRI/2024/12/077666已完成4 期
A Phase IV, Prospective, Multi-centre, Open label, Randomized Two-Arm Study to Assess the Safety, Tolerability and Efficacy of Inosine Pranobex 500 and 1000 mg Tablets Manufactured by Themis Medicare Ltd in Patients with Influenza and Other Acute Respiratory Viral Infections.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The proportion of subjects reporting treatment-emergent AEs (TEAEs) at EOS.
研究概览
简要总结
This is a Phase IV, prospective, open-label, multi-centre phase randomized controlled trial of Viralex® 500mg and Viralex® 1000mg tablets in subjects with Influenza and other acute respiratory viral Infections as per the marketing authorization in India for assessment of safety and efficacy. The subjects will be randomized to receive either Inosine Pranobex 500 mg tablet or Inosine Pranobex 1000 mg tablets in a 1:1 ratio, in doses and duration as defined in this study protocol.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female subjects greater than or equal to 12 to less than or equal to 65 years of age presenting with clinical signs and symptoms indicating influenza and or other acute respiratory viral infections.
- •Signs and symptoms of influenza can include some or all of these symptoms: fever or feeling feverish, chills, cough, sore throat, runny or stuffy nose, muscle or body aches, headache, fatigue (tiredness), and sometimes diarrhoea or vomiting.
- •Signs and symptoms of acute respiratory viral infections: Body temperature greater than or equal to 100 degree Fahrenheit, plus or minus At least one respiratory symptom (cough, sore throat, or nasal obstruction) plus or minus At least one constitutional symptom (fatigue, headache, myalgia, or feverishness)
- •Agreeing to provide informed consent (by the parents or legally acceptable or authorized representative (LAR) and assent (written assent for 12 to 17 year old children), as required, prior to study enrolment and to comply with study procedures
- •Subjects agreeing not to participate in another clinical trial during the study period.
- •Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
- •Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28.
排除标准
- •Subjects with known hypersensitivity to any of the ingredients of the Inosine Pranobex.
- •Subject with a history of gout or hyperuricemia (serum uric acid level greater than 8 mg per dl).
- •Subjects with signs, symptoms or having laboratory results suggestive of bacterial etiology.
- •Subject requiring mechanical ventilation or extracorporeal membrane oxygenation at screening.
- •Subjects who are undergoing treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents or treatment with thiazide (for example hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (for example furosemide, torsemide, and ethacrynic acid).
- •Subject with a history of renal or hepatic impairment.
- •Any subject who had received more than 1 dose of influenza antiviral medication (for example, oseltamivir or zanamivir), or any dose of ribavirin within 2 weeks, prior to the first study drug intake, or received intravenous peramivir greater than 1 day prior to screening.
- •Subjects with any serious disease condition or disorder that in the opinion of the investigator should preclude participation.
- •Female subjects with known pregnancy or actively breastfeeding.
- •Subjects with exacerbated or decompensated chronic diseases affecting the participants ability to participate in the clinical trial.
- •Subjects with malabsorption syndrome, including congenital or acquired conditions.
- •Subjects with a history of bronchial asthma.
- •Subjects with a history of convulsion or epilepsy.
- •Subjects with severe decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the subjects prognosis, and make him or her ineligible for the clinical study).
- •Subjects with compromised hepatic or renal function, as shown by but not limited to baseline AST or ALT 3 times the upper limit of the normal range, serum creatinine greater than or equal 2.0 mg per dl and or BUN greater than or equal 30 mg per dl, respectively.
- •Subjects with a history of oncological diseases, HIV, tuberculosis.
- •Subjects who received antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
- •Subjects having difficulty in dosing or consuming the oral medication or with any condition, which in the opinion of the investigators makes the subject unsuitable for inclusion.
结局指标
主要结局
The proportion of subjects reporting treatment-emergent AEs (TEAEs) at EOS.
时间窗: Day 10, End of Study
次要结局
- 1. The proportion of subjects reporting SAEs at End of the study(2. Tolerability and efficacy on clinical Global Impression Scale)
研究者
Dr Balaji More
Themis Medicare Limited
研究点 (5)
Loading locations...
相似试验
招募中
3 期
PH 3b, CAB + RPV in people with suboptimal response to oral ART (CROWN)HIV Infections2024-515070-28-00Viiv Healthcare UK Limited56
招募中
Unknown
To evaluate the safety and effectiveness of GolimuRel in patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ulcerative Colitis. Golimurel will be administered in a total of 225 patients of these three indications and safety profile will be be evaluated as primary outcome in these patients.CTRI/2025/08/092889Reliance Life Sciences Pvt Ltd225
招募中
2 期
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 PatientsImmunodeficiencyNCT07406217Calmy Alexandra256
招募中
3 期
A study to test whether exposure to BI 690517 in combination with empagliflozin helps people participants with heart failureCTRI/2025/02/081078Boehringer Ingelheim International GmbH6,000
招募中
4 期
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult PopulationsNCT07354269Sinovac Biotech Co., Ltd180