Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
NCT ID: NCT03116191
Last Updated: 2018-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2017-02-23
2017-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SK-1404 high dose
SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
SK-1404 middle dose
SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
SK-1404 low dose
SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
Placebo
Placebo
4 weeks of repeated administration of Placebo to the patients of nocturia
Interventions
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SK-1404
4 weeks of repeated administration of SK-1404 to the patients of nocturia
Placebo
4 weeks of repeated administration of Placebo to the patients of nocturia
Eligibility Criteria
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Inclusion Criteria
* NPI \>0.33
Exclusion Criteria
* 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
55 Years
79 Years
ALL
No
Sponsors
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Sanwa Kagaku Kenkyusho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Investigational site (there may be other sites in this country)
Tokyo, , Japan
Countries
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Other Identifiers
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VA1001
Identifier Type: -
Identifier Source: org_study_id
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