UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050468 |
|---|---|
| Receipt number | R000057478 |
| Scientific Title | Evaluation of blood concentration of oxytocin in hypertonic saline test |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/09/01 10:52:16 |
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Basic information
Public title
Evaluation of blood concentration of oxytocin in hypertonic saline test
Acronym
Evaluation of blood concentration of oxytocin in hypertonic saline test
Scientific Title
Evaluation of blood concentration of oxytocin in hypertonic saline test
Scientific Title:Acronym
Evaluation of blood concentration of oxytocin in hypertonic saline test
Region
| Japan |
Condition
Condition
Central diabetes insipidus, diencephalohypophysial diseases
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in blood concentration of oxytocin in hypertonic saline test in patients with diencephalohypophysial diseases (without central diabetes insipidus)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood concentration of oxytocin in hypertonic saline test in patients with diencephalohypophysial diseases (without central diabetes insipidus)
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Hypertonic saline infusion test
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected to have central diabetes insipidus or diencephalohypophyseal diseases
Key exclusion criteria
Patients with hypernatremia (serum sodium concentration higher than or equal to 150 mEq/L)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2142
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hagiwara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2142
Homepage URL
d-hagiwarai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
YAMASA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2973
ethics@med.nagoya-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057478
