Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria i... | NCT03116191

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

NCT03116191

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Status

Completed

Last Update Posted

Apr 13, 2018Actual

Enrollment

125Actual

Phase

Phase 2

Conditions

Nocturia Due to Nocturnal Polyuria

Interventions

SK-1404
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2017Actual

Primary Completion Date

Dec 15, 2017Actual

Completion Date

Dec 15, 2017Actual

First Submitted Date

Apr 6, 2017

First Submission Date that Met QC Criteria

Apr 11, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2018

Last Update Posted Date

Apr 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SK-1404 high dose	Experimental	Drug: SK-1404
SK-1404 middle dose	Experimental	Drug: SK-1404
SK-1404 low dose	Experimental	Drug: SK-1404
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SK-1404	Drug	4 weeks of repeated administration of SK-1404 to the patients of nocturia	SK-1404 high dose SK-1404 low dose SK-1404 middle dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change from base line in mean nocturnal urine volume	Assessed by the voiding diary	4 weeks
Change from base line in mean time to first awakening to void	Assessed by the voiding diary

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site (there may be other sites in this country)		Tokyo			Japan