NCT01280188已完成3 期
Peroral Administration of Different Doses of Desmopressin Administered as a New Orally-Disintegrating Tablet and Desmopressin for Nasal Administration in the Treatment of CDI in Japanese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Change from Baseline in 24-hour Urine Volume
研究概览
简要总结
This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI) patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of desmopressin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):
- •Failure to increase urine osmolality above 300 mOsm/kg during a period of fluid deprivation sufficient to raise plasma osmolality and sodium above the upper limit of normal level for the reference laboratory (usually 295 mOsm/kg and 148 mEq/l, respectively)
- •Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication.
- •A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.
- •Absence of the posterior pituitary bright spot on T-1 weighted midsagittal magnetic resonance imaging (MRI) of the brain.
- •Given written informed consent prior to any trial-related procedure is performed
- •24 hour urine volume (mL), urine osmolality (mOsm/kg), urine specific gravity, and serum sodium (mEq/L) maintained at a normal level by desmopressin nasal administration
- •Outpatient
- •The participant is, in the investigator's opinion, otherwise healthy
- •Be willing and able to comply with the protocol requirements including restriction of water intake
排除标准
- •Presence or a history of nephrogenic diabetes insipidus or diabetes mellitus
- •Presence of uncorrected hypothyroidism, hypoadrenalism or hypogonadism
- •Abnormalities or disease of the oral cavity that might affect the release and absorption of drug
- •Unable to be placed on water-intake restriction starting from two hours before bedtime
- •Presence of a hypothalamus abnormality leading to thirst disorder
- •Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
- •Uncontrolled hypertension
- •Treatment with another investigational product within the past 3 months
- •Concurrent treatment with diuretics, chlorpropamide, tricyclic antidepressants, indomethacin, carbamazepine
- •Alcohol dependency or drug abuse
- •Breastfeeding, pregnant, or likely to become pregnant
- •A mental condition, the lack of decision-making ability, dementia or a speech handicap
- •Any other reason that the Investigator believes inappropriate
研究组 & 干预措施
Desmopressin
Experimental
Day 1 - participants continue desmopressin intranasal. Day 2 up to Day 4 - Desmopressin oral melt to optimum dose. Continue optimum dose for the four week treatment and one year follow-up periods.
干预措施: Desmopressin Oral Melt (Drug)
Desmopressin
Experimental
Day 1 - participants continue desmopressin intranasal. Day 2 up to Day 4 - Desmopressin oral melt to optimum dose. Continue optimum dose for the four week treatment and one year follow-up periods.
干预措施: Desmopressin intranasal (Drug)
结局指标
主要结局
Change from Baseline in 24-hour Urine Volume
时间窗: Day 0, Week 4
次要结局
- Serum sodium level(up to Month 13)
- Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity(Day 0, Week 4)
- Participants with Adverse Events Summarized by Incidence and Severity(up to Month 13)
- 24-hour urine volume (mL)(Day 0, Week 4)
- Hourly diuresis rate (mL/hr)(Day 0, Week 4)
- Urine osmolality (mOsm/kg)(Day 0, Week 4)
- Urine specific gravity (g/mL)(Day 0, Week 4)
研究者
研究点 (5)
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