Efficacy and Safety of an Antiviral Polymeric Nasal Spray: A Randomized, Parallel Group, Double-blind, Placebo-controlled Study in Subjects With Early Symptoms of Common Cold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 163
- 试验地点
- 6
- 主要终点
- Symptoms of the Common Cold
研究概览
简要总结
This study will test 200 people to see if an experimental nasal spray has an effect on symptoms of the common cold if used when the symptoms start. At the first visit to the clinic, potential subjects will have tests to make sure they qualify to participate in the study.
If they qualify, they will have an equal chance of receiving the experimental nasal spray or a sham nasal spray (one that does not have the experimental formula). At the first visit, subjects will receive their assigned nasal spray and use it once at the clinic. They will also receive a booklet called a diary. Subjects will take the rest of their treatments for day 1 at home, and for the next six days, they will use the nasal spray four times per day and record their symptoms in the diary, as instructed. Then subjects will come back to the clinic for a final visit.
详细描述
This is an investigation in healthy subjects with early signs of common cold. Subjects will be randomly assigned in a 1:1 ratio to receive either Polymeric Nasal Spray or a matching placebo nasal spray.
Subjects will be screened for eligibility and randomized to treatment at the Screening/ Randomization Visit (Day 1). Subjects will apply the first dose of the nasal spray at this visit under supervision. The other applications will take place at home on Day 1. On Days 2 through 7, subjects will use their assigned nasal spray as 2 sprays per nostril, 4 times per day.
One Follow up Visit will be conducted within 3 days of the last application of nasal spray.
Enrollment will continue until 200 subjects have completed the investigation (100 per treatment group). The subject and the investigative staff will be blinded to the assigned nasal spray.
Efficacy will be measured, and recorded in the subject's diary, and safety will be assessed by reported AEs and ADEs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have early signs of a common cold: If female of child-bearing potential, have a negative pregnancy test at Screening.
- •Have signed and dated the informed consent document, indicating that they have been informed of all pertinent aspects of the investigation
- •Are willing and able to comply with scheduled visits, treatment plan, and other investigation procedures
排除标准
- •Have had common cold or flu-like symptoms outside the protocol-specified parameters.
- •Are current smokers as defined by the protocol.
- •Have any medical history or condition or use any drug or device that (per protocol or in the opinion of the investigator) might compromise subject safety, participation in the trial, action of the investigational device, or results of the investigation..
- •Are related to anyone involved with the conduct of the investigation.
结局指标
主要结局
Symptoms of the Common Cold
时间窗: Within 7 days
Subjects will score their symptoms of the common cold including local symptoms (sore throat, blocked nose, runny nose, cough, and sneezing) and systemic symptoms (headache, muscle ache, and chilliness) on a scale of 0-3, where 0=: None (symptoms not present in the previous 24 hours) and 3= Severe (symptoms disturbing/irritating most of the time).
次要结局
- Effect of Common Cold on Daily Activities(Within 7 days)
- Effect of Common Cold Symptoms on Sleep(Within 7 days)
- Number of Days Lost(Within 7 days)
- Treatment Outcome(Within 7 days)