NCT00806468终止4 期
A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- average nocturnal micturition frequency within the 2 weeks treatment phase each
研究概览
简要总结
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with idiopathic Parkinson Syndrome
- •18 to 85 years
- •Nocturnal Pollakisuria > 2 mictions /night (documented in Screening phase )
- •Na+ i.S > 135 mmol/l
- •Patient is able to understand all aspects and individual consequences of the clinical trial
- •An informed consent signed and dated by the patient is available prior to any study specific treatment
- •The study is consistent with the patients´ request for an appropriate treatment
排除标准
- •Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
- •Central Diabetes insipidus
- •Known heart insufficiency (NYHA Stad. III und IV)
- •clinical relevant kidney insufficiency
- •Habitual and psychogenic Polydipsia
- •Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
- •Participation in another clinical trial during or within 6 months prior to this clinical trial
- •Medical or psychological condition, which might endanger the proper conduction of the clinical trial
- •Known drug or alcohol abuse
研究组 & 干预措施
Desmopressin
Experimental
Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.
干预措施: Desmotabs (Drug)
结局指标
主要结局
average nocturnal micturition frequency within the 2 weeks treatment phase each
时间窗: 6 weeks
次要结局
- safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome(8 weeks)
研究者
研究点 (1)
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