Nocturia Due to Nocturnal Polyuria
Conditions
Brief summary
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
Interventions
DRUGSK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
DRUGPlacebo
4 weeks of repeated administration of Placebo to the patients of nocturia
Sponsors
Sanwa Kagaku Kenkyusho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 5 \> nocturnal voids ≥2 * NPI \>0.33
Exclusion criteria
* Polydipsia * Cardiac failure * Syndrome of inappropriate antidiuretic hormone secretion * Hyponatraemia * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Moderate or severe over-active bladder (OAB) * Severe benign prostate hyperplasia (BPH) * Sleep apnoea * Interstitial cystitis * Stress urinary incontinence * Diabetes insipidus * Complication or a history of urological cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean number of nocturnal voids | 4 weeks | Assessed by the voiding diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from base line in mean nocturnal urine volume | 4 weeks | Assessed by the voiding diary |
| Change from base line in mean time to first awakening to void | 4 weeks | Assessed by the voiding diary |
| Change from base line in mean Nocturnal Polyuria Index (NPI) | 4 weeks | Assessed by the voiding diary |
| Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) | 4 weeks | Assessed by the voiding diary |
Countries
Japan
Outcome results
None listed