Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
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Keep this study
Lead
Ferring Pharmaceuticals
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent prior to performance of any trial-related activity
Male sex 18 years of age or older
At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.
You may not be if
Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
Interstitial Cystitis
Chronic prostatitis/chronic pelvic pain syndrome
Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
Central or nephrogenic diabetes insipidus.
Syndrome of inappropriate anti-diuretic hormone.
Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
Hyponatraemia: Serum sodium level must be within normal limits
Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
History of obstructive sleep apnea
Previous desmopressin treatment for nocturia
Treatment with another investigational product within 3 months prior to screening
Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
Known alcohol or substance abuse
Work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers
Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial
Clareo Health | Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
