Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01262456
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01262456
Study Brief:
Protocol Section:
NCT01262456