A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 15
- 主要终点
- Change in the Number of Wet Nights Between Baseline and Treatment Period II
研究概览
简要总结
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
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
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
- •Age 6 or above but under 16 regardless of gender
- •Out-patient
- •Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
- •Deemed healthy by the investigator
- •Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
- •Consent from the pediatric patient's legally acceptable representative
- •Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
- •Show no possibility of being a nursing mother or pregnant, or becoming pregnant
- •If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment
排除标准
- •Suffer from enuresis with an underlying disease
- •Participated in another clinical trial within six months preceding consent
- •Used an intranasal Desmopressin in the past
- •Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
- •Have an anomaly or a disease that may affect the oral absorption of drug products
- •Hard to get cooperation from subject by school refusal, punishment or bullying
- •Deemed by the investigator to be inappropriate to participate in this trial
- •Unable to be placed on water-intake restriction starting from two hours before bedtime
- •Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
研究组 & 干预措施
Desmopressin
During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
干预措施: Desmopressin (Drug)
Placebo
Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Number of Wet Nights Between Baseline and Treatment Period II
时间窗: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.
次要结局
- Change in Number of Wet Nights Between Baseline and Treatment Period I(Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).)
- Change in Number of Wet Nights Between Treatment Periods I and II(Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4))