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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016915
Receipt No. R000019635
Scientific Title The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2
Date of disclosure of the study information 2015/03/25
Last modified on 2019/03/28

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Basic information
Public title The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2
Acronym Serum Copeptin and Urinary Aquaporin-2 Measurement in Nocturnal Enuresis Patients
Scientific Title The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2
Scientific Title:Acronym Serum Copeptin and Urinary Aquaporin-2 Measurement in Nocturnal Enuresis Patients
Region
Japan

Condition
Condition Monosymptomatic Nocturnal Enuresis
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate serum Copeptin and urinary Aquaporin-2 levels during the course of Desmopressin treatment in patients with mono symptomatic nocturnal enuresis
Basic objectives2 Others
Basic objectives -Others To assess whether serum Copeptin and/or urinary Aquaporin-2 is possible biomarkers for desmopressin treatment
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Serum Copeptin and urinary Aquaporin-2 levels: before the treatment, 4 and 8 weeks after the treatment, and after the treatment
Key secondary outcomes Urine volume during the night, urinary osmolarity and creatinine before and after sleep : before the treatment, 4 and 8 weeks after the treatment, and after the treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Oral desmopressin (Minirin Melt) 120 micrograms or 240 micrograms is given before sleep every day for 6 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
7 years-old <=
Age-upper limit
11 years-old >=
Gender Male and Female
Key inclusion criteria Patients with monosymptomatic nocturnal enuresis with more than 4 wet nights per week, without the previous history of desmopressin therapy
Key exclusion criteria Patients with underlying pathologic conditions such as renal, endocrine, metabolic and neurological disorders resulted in nocturnal enuresis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshiyuki
Middle name
Last name Ohtomo
Organization Juntendo University Nerima Hospital
Division name Department of Pediatrics
Zip code 1710033
Address 3-1-10 Takanodai, Nerima, Tokyo
TEL +81-3-59233111
Email ohtomo@juntendo-nerima.jp

Public contact
Name of contact person
1st name Miyuki
Middle name
Last name Katsuki
Organization Juntendo University Nerima Hospital
Division name GCP Center
Zip code 1710033
Address 3-1-10 Takanodai, Nerima, Tokyo
TEL +81-3-59233111
Homepage URL
Email gcp@juntendo-nerima.jp

Sponsor
Institute Department of Pediatrics, Juntendo University Graduated School of Medicine
Institute
Department

Funding Source
Organization Ferring Pharmaceuticals Co Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Pharmacology, Keio University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Nerima Hospital
Address 3-1-10 Takanodai, Nerima-ku, Tokyo
Tel 03-5923-3111
Email gcp@juntendo-nerima.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学医学部附属練馬病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2015 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 15 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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