UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047430 |
|---|---|
| Receipt number | R000054059 |
| Scientific Title | Clinical study on the effect of metyrosine on improving physiological and metabolic disorders in patients with pheochromocytoma/paraganglioma. |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/04/07 16:15:52 |
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Basic information
Public title
Clinical study on the effect of metyrosine on improving physiological and metabolic disorders in patients with pheochromocytoma/paraganglioma.
Acronym
Clinical study on the effect of metyrosine on improving physiological and metabolic disorders in patients with pheochromocytoma/paraganglioma.
Scientific Title
Clinical study on the effect of metyrosine on improving physiological and metabolic disorders in patients with pheochromocytoma/paraganglioma.
Scientific Title:Acronym
Clinical study on the effect of metyrosine on improving physiological and metabolic disorders in patients with pheochromocytoma/paraganglioma.
Region
| Japan |
Condition
Condition
pheochromocytoma/paraganglioma(PPGL)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacies of metyrosine administration in preoperative periods to the patients with PPGL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose metabolism(fasting blood glucose level,IRI,CPR,HOMA-beta,HOMA-IR)and decreased amount of catecholamines before and after administration of metyrosine.
Key secondary outcomes
Systolic and diastolic blood pressure and endocrine function (PRL, TSH, FT4, GH, IGF-1, PRA, PAC) before and after administration of metyrosine.
Blood pressure fluctuation, blood transfusion volume, urine volume, bleeding volume, phentolamine dose (mg), catecholamine usage before and after surgery.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Select the one that meets all of the following criteria
･Patients aged between 20 and 80 years old
･Patients who have given written consent to participate in the study.
However, if you have dementia or mental illness, the patient who obtained the consent of the substitute
･Patients who can or have undergone blood and urinalysis before and after PPGL treatment
Key exclusion criteria
Those who meet any of the following criteria are excluded from the target
･Patients with severe renal dysfunction(eGFR <30 mL/min)
･Lactating patients
･Patients judged by the principal investigator and the research coordinator to be inappropriate as research subjects
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Matsuo |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
8300011
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL
0942317563
matsuo_yuuko@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Matsuo |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
8300011
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL
0942317563
Homepage URL
matsuo_yuuko@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kurume University School of Medicine
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
Tel
0942653749
i_rinri@kurume-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
| 2022 | Year | 04 | Month | 11 | 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
12
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to confirm the effectiveness of metyrosine administration for physiological, metabolic, and endocrinological functions in the preoperative period of PPGL patients compared to surgical treatment.
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
