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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Current Primary Outcome: Change from baseline in mean number of nocturnal voids [ Time Frame: 4 weeks ]

Assessed by the voiding diary


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from base line in mean nocturnal urine volume [ Time Frame: 4 weeks ]
    Assessed by the voiding diary
  • Change from base line in mean time to first awakening to void [ Time Frame: 4 weeks ]
    Assessed by the voiding diary
  • Change from base line in mean Nocturnal Polyuria Index (NPI) [ Time Frame: 4 weeks ]
    Assessed by the voiding diary
  • Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) [ Time Frame: 4 weeks ]
    Assessed by the voiding diary


Original Secondary Outcome: Same as current

Information By: Sanwa Kagaku Kenkyusho Co., Ltd.

Dates:
Date Received: April 6, 2017
Date Started: February 23, 2017
Date Completion: January 2018
Last Updated: April 11, 2017
Last Verified: April 2017