UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046985 |
|---|---|
| Receipt number | R000053594 |
| Scientific Title | Research of Tolvaptan prescription in SIADH patients (Observational research using DPC) |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/07/14 19:05:03 |
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Basic information
Public title
Research of Tolvaptan prescription in SIADH patients
(Observational research using DPC)
Acronym
Research of Tolvaptan prescription in SIADH patients
Scientific Title
Research of Tolvaptan prescription in SIADH patients
(Observational research using DPC)
Scientific Title:Acronym
Research of Tolvaptan prescription in SIADH patients
Region
| Japan |
Condition
Condition
SIADH
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate Tolvaptan prescription in actual clinical practice in SIADH patients (starting dose, etc.) after the indication of "improvement of hyponatremia secondary to SIADH" was added in June 2020.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Tolvaptan prescription in actual clinical practice (starting dose, increase / decrease, prescription period, re-administration)
- Changes in serum sodium concentration, occurrence of rapid correction of hyponatremia (by Tolvaptan dose)
Key secondary outcomes
-Patient demographic and clinical characteristics
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with a diagnosis of "ICD10E222: Syndrome of inappropriate secretion of antidiuretic hormone <SIADH>" during the enrollment period
Key exclusion criteria
- Patients under 18 years old
Target sample size
2800
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL
080-6791-7646
Matsukawa.miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL
080-6791-7646
Homepage URL
Matsukawa.miyuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RIHDS Ethics Review Board
Address
2-5-5 Shibadaimon, Minato-ku, Tokyo Sumitomo Shibadaimon Building 12th floor, inside JMDC Co., Ltd.
Tel
03-5733-5010
rihds@jmdc.co.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
| 2022 | Year | 03 | 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
2800
Results
As a result of examination using actual clinical data using the DPC database, half of the tolvaptan starting dose to SIADH was started from a low dose (3.75 mg), and the average administration period was 32.7 days for 3.75 mg and 33.1 days for 7.5 mg. Since mean of the serum sodium concentration at the start of the tolvaptan-administered case was 120.30 mEq / L, it is considered that the appropriate starting dose was selected for administration.
Results date posted
| 2022 | Year | 07 | Month | 14 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 12 | Day |
Other
Other related information
Research of Tolvaptan prescription
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053594
