NCT03116191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

April 6, 2017

Last Update Submit

April 12, 2018

Conditions

Nocturia Due to Nocturnal Polyuria

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean number of nocturnal voids

    Assessed by the voiding diary

    4 weeks

Secondary Outcomes (4)

  • Change from base line in mean nocturnal urine volume

    4 weeks

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

    4 weeks

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

    4 weeks

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

    4 weeks

Study Arms (4)

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

SK-1404DRUG

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

SK-1404 high doseSK-1404 low doseSK-1404 middle dose
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> nocturnal voids ≥2
  • NPI \>0.33

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tokyo, Japan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 14, 2017

Study Start

February 23, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

JP(1)