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

Nocturia Due to Nocturnal Polyuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116191
• Other study ID #: VA1001
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2017
• Last updated: April 12, 2018
• Start date: February 23, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: April 2018
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Nocturia
• Nocturia Due to Nocturnal Polyuria
• Polyuria

Intervention

Drug:
• SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
• Placebo
4 weeks of repeated administration of Placebo to the patients of nocturia

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of nocturnal voids	Assessed by the voiding diary	4 weeks
Secondary	Change from base line in mean nocturnal urine volume	Assessed by the voiding diary	4 weeks
Secondary	Change from base line in mean time to first awakening to void	Assessed by the voiding diary	4 weeks
Secondary	Change from base line in mean Nocturnal Polyuria Index (NPI)	Assessed by the voiding diary	4 weeks
Secondary	Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)	Assessed by the voiding diary	4 weeks