EUCTR2016-003851-31-CZ进行中（未招募）1 期
A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, with Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia due to Nocturnal Polyuria in Adults - DAW
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 531
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* Adults =18 years of age (at the time of written consent)
- •* Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
- •* =2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
- •* The largest single voided volume must be = 200 mL (at least 1 void = 200 mL) as documented in the 3-day e-Diary prior to Visit 2* Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour)urine volume as documented in the 3-day e-Diary prior to Visit 2
- •* =20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •* Current diagnosis of Obstructive Sleep Apnoea (OSA).
- •* Restless Legs Syndrome (RLS)
- •* Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed
- •by uroflowmetry upon suspicion during screening prior to Visit 2
- •* Urinary incontinence defined as an average of >1 episode/day in the
- •3-day e-Diary prior to Visit 2 (occasional urge incontinence during
- •daytime or at night on the way to void is not necessarily exclusionary)
- •* Any pelvic or lower urinary tract surgery and/or radio therapy or
- •previous pelvic irradiation within the past 6 months prior to Visit 1.
- •Including e.g., transurethral resection for Bladder Outlet Obstruction or
- •Benign Prostatic Hyperplasia, hysterectomy or female incontinence
- •* Genito-urinary tract pathology that can in the investigator’s opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
- •* A history of cancer with the last date of disease activity/prescence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
- •* History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson’s, spinal cord injury, spina bifida)
- •* Habitual (fluid intake >3L per day) or psychogenic polydipsia
- •* Uncontrolled hypertension, as judged by the investigator
- •* Uncontrolled diabetes mellitus, as judged by the investigator
- •* Central or nephrogenic diabetes insipidus
- •* Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
- •* History of gastric retention
- •* Suspicion or evidence of congestive heart failure, (New York Heart Association [NYHA] class
- •II, III, IV)
- •* Hyponatraemia:
- •- Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
- •- Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
- •* Use of any prohibited therapy listed below:
- •- Current or former (within 3 months prior to screening) treatment with any other IMP
- •- Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable
- •electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
- •- Thiazide diuretics
- •- Antiarrhythmic agents
- •- V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
- •- Loperamide
- •- Botulinum toxin (cosmetic non-urological use is acceptable)
- •- Valproate
研究者
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