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

Primary Purpose

Nocturia Due to Nocturnal Polyuria

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

SK-1404

Placebo

About this trial

This is an interventional treatment trial for Nocturia Due to Nocturnal Polyuria

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Investigational site (there may be other sites in this country)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SK-1404 high dose

SK-1404 middle dose

SK-1404 low dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean number of nocturnal voids

Assessed by the voiding diary

Secondary Outcome Measures

Change from base line in mean nocturnal urine volume

Assessed by the voiding diary

Change from base line in mean time to first awakening to void

Assessed by the voiding diary

Change from base line in mean Nocturnal Polyuria Index (NPI)

Assessed by the voiding diary

Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

Assessed by the voiding diary

Full Information

NCT ID

NCT03116191

First Posted

April 6, 2017

Last Updated

April 12, 2018

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03116191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 23, 2017 (Actual)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturia Due to Nocturnal Polyuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SK-1404 high dose

Arm Type

Experimental

Arm Title

SK-1404 middle dose

Arm Type

Experimental

Arm Title

SK-1404 low dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SK-1404

Intervention Description

4 weeks of repeated administration of SK-1404 to the patients of nocturia

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4 weeks of repeated administration of Placebo to the patients of nocturia

Primary Outcome Measure Information:

Title

Change from baseline in mean number of nocturnal voids

Description

Assessed by the voiding diary

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change from base line in mean nocturnal urine volume

Description

Assessed by the voiding diary

Time Frame

4 weeks

Title

Change from base line in mean time to first awakening to void

Description

Assessed by the voiding diary

Time Frame

4 weeks

Title

Change from base line in mean Nocturnal Polyuria Index (NPI)

Description

Assessed by the voiding diary

Time Frame

4 weeks

Title

Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

Description

Assessed by the voiding diary

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Investigational site (there may be other sites in this country)

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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