Status and phase
Conditions
Treatments
About
Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (for subjects who participated in trials 000129 or 000130):
Exclusion Criteria (for subjects who participated in trials 000129 or 000130):
Inclusion Criteria (for subjects who did not participate in trials 000129 or 000130):
Exclusion Criteria (for subjects who did not participate in trials 000129 or 000130):
Early withdrawal from clinical trial 000129 or 000130
Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 1b
History or evidence of significant obstructive sleep apnoea
History or diagnosis of any of the following urological diseases:
Interstitial cystitis or bladder pain disorder
In males, 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 prostatitis/chronic pelvic pain syndrome
Surgical treatment, including transurethral resection, for BOO or BPH within the past 6 months prior to Visit 1a
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 1a
Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1a
Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1a
History of any neurological disease affecting bladder function or muscle strength at Visit 1a
Habitual or psychogenic polydipsia based on medical history at Visit 1a or 24-hour urine output of >2.8 L based on the voiding diary at Visit 1b
Central or nephrogenic diabetes insipidus at Visit 1a
Syndrome of inappropriate antidiuretic hormone secretion at Visit 1a
Suspicion or evidence of cardiac failure at Visit 1a
Uncontrolled hypertension at Visit 1a and Visit 1b
Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1a Renal insufficiency at Visit 1a and Visit 1b
Renal insufficiency at Visit 1a and Visit 1b
Hepatic and/or biliary diseases at Visit 1a and Visit 1b
Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1a
In females, pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
Known alcohol or substance abuse at Visit 1a
Work or lifestyle that may interfere with regular night-time sleep at Visit 1a, 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 1a
Use of any prohibited therapy during the trial period
Primary purpose
Allocation
Interventional model
Masking
503 participants in 8 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal