CompletedPhase 2

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

Japan125 participantsStarted 2017-02-23

Plain-language 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.

Who can participate

Age range55 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline in mean number of nocturnal voids

Timeframe: 4 weeks

Trial details

NCT IDNCT03116191

SponsorSanwa Kagaku Kenkyusho Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-15

View on ClinicalTrials.gov More Nocturia Due to Nocturnal Polyuria trials