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

April 12, 2018 updated by: Sanwa Kagaku Kenkyusho Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Investigational site (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
4 weeks of repeated administration of Placebo to the patients of nocturia
Experimental: SK-1404 high dose
Drug: SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
Experimental: SK-1404 middle dose
Drug: SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
Experimental: SK-1404 low dose
Drug: SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean number of nocturnal voids
Time Frame: 4 weeks
Assessed by the voiding diary
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from base line in mean nocturnal urine volume
Time Frame: 4 weeks
Assessed by the voiding diary
4 weeks
Change from base line in mean time to first awakening to void
Time Frame: 4 weeks
Assessed by the voiding diary
4 weeks
Change from base line in mean Nocturnal Polyuria Index (NPI)
Time Frame: 4 weeks
Assessed by the voiding diary
4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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