A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.
研究概览
简要总结
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
详细描述
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children suffering from primary nocturnal enuresis with no organic pathology.
- •Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
- •Children with a minimum of 6 wet nights in 2 weeks.
排除标准
- •Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
- •Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
- •Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
- •Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
研究组 & 干预措施
1
干预措施: MINIRIN Oral Lyophilisate (Drug)
2
干预措施: Minirin tablet (Drug)
结局指标
主要结局
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.
时间窗: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
次要结局
- Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.(3 weeks)
- The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.(3 weeks)
- Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.(3 weeks)
- Safety comparison between the 2 formulations.(6 weeks)
- Comparison of compliance between the 2 formulations.(6 weeks)
- The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.(6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.)