Clinical trial NCT01262456 (phase 3, status: completed)
Conditions: nocturia
ICD codes: R35.1
Drugs: desmopressin, placebo
SMILES: NC(=O)CC[C@@H]1NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CC2=CC=C(O)C=C2)NC(=O)CCSSC[C@H](NC(=O)[C@H](CC(N)=O)NC1=O)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(N)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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

          -  Neurogenic detrusor activity (detrusor overactivity)

          -  Suspicion or evidence of cardiac failure

          -  Uncontrolled hypertension

          -  Uncontrolled diabetes mellitus

          -  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