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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021900
Receipt No. R000025247
Scientific Title The study on the safety of perchlorate discharge test for Pendred syndrome patients
Date of disclosure of the study information 2016/04/19
Last modified on 2019/03/29

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Basic information
Public title The study on the safety of perchlorate discharge test for Pendred syndrome patients
Acronym The study on the safety of perchlorate test
Scientific Title The study on the safety of perchlorate discharge test for Pendred syndrome patients
Scientific Title:Acronym The study on the safety of perchlorate test
Region
Japan

Condition
Condition Pendred syndrome
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove the safety of perchrolate discharge test for Pendred syndrome patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To assess the safety. Intake rate test by scintigraphy is performed 3 hrs after 123I intake.
Key secondary outcomes To assess the efficacy. Intake rate and thyroid function tests are performed after perchlorate administration.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Intake rate test by schincigraphy is performed 3 hrs after induction of 123I intake. Perchlorate (20 mg/kg for over 3 years old (e.g.0.6 g for 6 years old) and 1.0 g for over 50 kg body weight or adults)is administerred when intake rate is above the set point.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who are eligible to the follosing criteria.
1) Pendred syndrome suspected patients with sensorineural hearing loss and thyroid goiter.
2) Patients or their guardians if the patients are children who understand our explanation completely with written informed consent signed and dated.
Key exclusion criteria 1) Patients who do not consent to our study.
2) Patients judged by investigators ineligible due to seriousness of patients condition.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Tanaka
Organization Chiba University Graduate School of Medicine
Division name Clinical Cell Biology and Medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Email tomoaki@restaff.chiba-u.jp

Public contact
Name of contact person
1st name Hisashi
Middle name
Last name Koide
Organization Chiba University Graduate School of Medicine
Division name Clinical Cell Biology and Medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email koideh@chiba-u.jp

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization Self funding
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 Chiba university hospital
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Japan
Tel 0432227171
Email tomoaki@restaff.chiba-u.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
2016 Year 04 Month 19 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 Completed
Date of protocol fixation
2015 Year 12 Month 24 Day
Date of IRB
2016 Year 02 Month 16 Day
Anticipated trial start date
2016 Year 02 Month 17 Day
Last follow-up date
2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 13 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025247

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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