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

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 2

Conditions: Nocturia Due to Nocturnal Polyuria

Treatments: Drug: Placebo; Drug: SK-1404

Study type: Interventional

Funder types: Industry

Identifiers

NCT03116191

VA1001

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 4 patient groups, including a placebo group

SK-1404 high dose

Experimental group

Treatment:

Drug: SK-1404

SK-1404 middle dose

Experimental group

Treatment:

Drug: SK-1404

SK-1404 low dose

Experimental group

Treatment:

Drug: SK-1404

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo