Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Condition: Nocturia
MeSH terms: Nocturia
Intervention: Desmopressin; Placebo
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 268.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to
      investigate the safety and efficacy of desmopressin oral melt tablets against placebo during
      3 months of treatment in adult females with nocturia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to performance of any trial-related activity

          -  Female sex 18 years of age or older

          -  At least 2 voids every night in a consecutive 3-day period during the screening period

        Exclusion Criteria:

          1. 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)

          2. Interstitial cystitis

          3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by
             bladder ultrasound performed after suspicion of urinary retention

          4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production
             exceeding 40 mL/kg/24 hours)

          5. Central or nephrogenic diabetes insipidus

          6. Syndrome of inappropriate anti-diuretic hormone secretion

          7. Current or a history of urologic malignancies e.g. bladder cancer

          8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra
             causing symptoms

          9. Neurogenic detrusor activity (detrusor overactivity).

         10. Suspicion or evidence of cardiac failure

         11. Uncontrolled hypertension

         12. Uncontrolled diabetes mellitus

         13. Hyponatraemia: Serum sodium level must be within normal limits

         14. Renal insufficiency: Serum creatinine must be within normal limits and estimated
             glomerular filtration rate must be more than or equal to 50 mL/min

         15. 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

         16. History of obstructive sleep apnea

         17. Previous desmopressin treatment for nocturia

         18. Treatment with another investigational product within 3 months prior to screening

         19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide,
             torsemide, ethacrynic acid) and any other investigational drug

         20. Pregnancy, breastfeeding, or a plan to become pregnant during the period of the
             clinical trial. Subjects of reproductive age must have documentation of a reliable
             method of contraception. All pre-and perimenopausal subjects have to perform pregnancy
             tests. Amenorrhea of more than 12 months' duration based on the reported date of the
             last menstrual period is sufficient documentation of post-menopausal status and does
             not require a pregnancy test

         21. Known alcohol or substance abuse

         22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers

         23. 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