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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03116191 |
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Date of registration:
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06/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
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Scientific title:
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Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects |
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Date of first enrolment:
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February 23, 2017 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03116191 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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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
Age minimum:
55 Years
Age maximum:
79 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nocturia Due to Nocturnal Polyuria
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Intervention(s)
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Drug: SK-1404
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline in mean number of nocturnal voids
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Change from base line in mean Nocturnal Polyuria Index (NPI)
[Time Frame: 4 weeks]
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Change from base line in mean nocturnal urine volume
[Time Frame: 4 weeks]
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Change from base line in mean time to first awakening to void
[Time Frame: 4 weeks]
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Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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