NCT05178641已完成不适用
Overnight Pant Safety-in-use Diary Clinical Trial for Children With Nocturnal Enuresis
Procter and Gamble2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number, Frequency and Severity of Product Related Adverse Events
研究概览
简要总结
This study will evaluate the in-use tolerance of an absorbent disposable underwear pant developed for children with nocturnal enuresis by assessing adverse events. In addition product performance will be assessed by the parent at home via a daily diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:
- •Have you read, understood and signed the Informed Consent document?
- •Is your child generally healthy?
- •Is your child 4-7 years of age?
- •Does your child weigh approximately 37-63 pounds and fit into the test pant?
- •Thinking of the past 3 months, does your child wet the bed at night at least once per week?
- •Is your child currently using overnight pants or diapers?
- •Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?
- •Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?
- •Are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial?
- •Are you and your child willing to refrain from using lotions, creams, ointments, oils, moisturizing bubble baths, powders, sunscreen and/or skin preparations in the child's pant area and on thighs for the duration of this clinical trial, unless required for medical reasons?
- •Are you and your child willing and able to comply with all study instructions?
- •Are you able to fill in the required questionnaires in English?
排除标准
- •Participants are ineligible for enrollment if the parent/legal guardian responds positively ("Yes") to any of the following questions:
- •Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?
- •Does your child currently have (or have a history of) any significant illness or chronic medical condition?
- •Is your child currently using any medications?
- •Does your child currently wear absorbent products during the day?
- •Does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?
结局指标
主要结局
Number, Frequency and Severity of Product Related Adverse Events
时间窗: From admission to discharge, up to 6 weeks
Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.
次要结局
- Parent Assessed Product Performance in Terms of Urine Leaking(From admission to discharge, up to 6 weeks)
研究者
研究点 (2)
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