Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Sanwa Kagaku Kenkyusho Co., Ltd.125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Nocturia Due to Nocturnal Polyuria

Interventions

SK-1404DRUG

4 weeks of repeated administration of SK-1404 to the patients of nocturia

PlaceboDRUG

4 weeks of repeated administration of Placebo to the patients of nocturia

Eligibility

Sex: ALLMin age: 55 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline in mean number of nocturnal voids

Assessed by the voiding diary

Time frame: 4 weeks

Secondary Outcomes

Change from base line in mean nocturnal urine volume

Assessed by the voiding diary

Time frame: 4 weeks

Change from base line in mean time to first awakening to void

Assessed by the voiding diary

Time frame: 4 weeks

Change from base line in mean Nocturnal Polyuria Index (NPI)

Assessed by the voiding diary

Time frame: 4 weeks

Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

Assessed by the voiding diary

Time frame: 4 weeks

Data from ClinicalTrials.gov

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