Status and phase
Conditions
Treatments
About
The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
History or evidence of significant obstructive sleep apnoea
History or diagnosis of any of the following urological diseases at Visit 1:
Interstitial cystitis or bladder pain disorder
Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and:
Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
Chronic pelvic pain syndrome
Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1
Symptoms of severe over-active bladder (OAB):
Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1
Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1
Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1
History of any neurological disease affecting bladder function or muscle strength at Visit 1
Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of >2.8 L based on the voiding diary at Visit 2
Central or nephrogenic diabetes insipidus at Visit 1
Syndrome of inappropriate antidiuretic hormone secretion at Visit 1
Suspicion or evidence of cardiac failure at Visit 1
Uncontrolled hypertension at Visit 1
Uncontrolled diabetes mellitus at Visit 1
Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1
Renal insufficiency at Visit 1
Hepatic and/or biliary diseases at Visit 1
Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1
Known alcohol or substance abuse at Visit 1
Work or lifestyle that may interfere with regular night-time sleep at Visit 1, 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 at Visit 1
Use of any prohibited therapy during the trial period
Primary purpose
Allocation
Interventional model
Masking
342 participants in 3 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal