Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
- Registration Number
- NCT03116191
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SK-1404 low dose SK-1404 - Placebo Placebo - SK-1404 high dose SK-1404 - SK-1404 middle dose SK-1404 -
- Primary Outcome Measures
Name Time Method Change from baseline in mean number of nocturnal voids 4 weeks Assessed by the voiding diary
- Secondary Outcome Measures
Name Time Method Change from base line in mean time to first awakening to void 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
Change from base line in mean nocturnal urine volume 4 weeks Assessed by the voiding diary
Change from base line in mean Nocturnal Polyuria Index (NPI) 4 weeks Assessed by the voiding diary
Trial Locations
- Locations (1)
Investigational site (there may be other sites in this country)
🇯🇵Tokyo, Japan