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

• Status: Completed
• Trial end date: 2017-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Criteria

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