CompletedNCT03116191Updated Apr 13, 2018

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

A Phase 2 interventional study of SK-1404 and Placebo in Nocturia Due to Nocturnal Polyuria, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 125
Allocation: Randomized
Ages: 55 Years to 79 Years
Sex: All

Study 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.

Conditions studied

Nocturia Due to Nocturnal Polyuria

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Who can participate

Ages eligible: 55 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

5 > nocturnal voids ≥2
NPI >0.33

Exclusion criteria

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 125 participants (actual)

Study arms

Experimental
SK-1404 high dose
Drug: SK-1404
Experimental
SK-1404 middle dose
Drug: SK-1404
Experimental
SK-1404 low dose
Drug: SK-1404
Placebo comparator
Placebo
Drug: Placebo

Interventions

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

What researchers measure

Primary outcomes

Change from baseline in mean number of nocturnal voids
Assessed by the voiding diary
Time frame: 4 weeks

Secondary outcomes

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

Study locations

1 site

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

Registry details

Key details

Study ID: NCT03116191
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Responsible party: Sponsor
First posted: Apr 14, 2017
Start date: Feb 23, 2017
Primary completion: Dec 15, 2017
Completion: Dec 15, 2017
Last update: Apr 13, 2018

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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