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Recruitment status Completed
Unique ID issued by UMIN UMIN000015116
Receipt No. R000017587
Scientific Title Investigation of hyperammonemia due to valproic acid in Okinawa
Date of disclosure of the study information 2014/09/12
Last modified on 2018/10/22

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Basic information
Public title Investigation of hyperammonemia due to valproic acid in Okinawa
Acronym Investigation of hyperammonemia due to valproic acid in Okinawa
Scientific Title Investigation of hyperammonemia due to valproic acid in Okinawa
Scientific Title:Acronym Investigation of hyperammonemia due to valproic acid in Okinawa
Region
Japan

Condition
Condition psychiatric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation for safety evaluation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood valproic acid level, blood ammonia level, blood carnitine level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The person who takes valproic acid
The person with the ability for agreement
Key exclusion criteria The pregnancy or the person who has the possibilities
The person that ability for agreement has a problem
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Nakamura
Organization University of the Ryukyus, School of medicine
Division name Department of neuropsychiatry
Zip code
Address 207 Uehara, Nishihara-cho
TEL 098-895-1157
Email anakamura-oki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akifumi Nakamura
Organization University of the Ryukyus, School of medicine
Division name Department of neuropsychiatry
Zip code
Address 207 Uehara, Nishihara-cho
TEL 098-895-1157
Homepage URL
Email anakamura-oki@umin.ac.jp

Sponsor
Institute University of the Ryukyus, School of medicine, Department of neuropsychiatry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization University of the Ryukyus, School of medicine, Department of neuropsychiatry
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
Address
Tel
Email

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
2014 Year 09 Month 12 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
Plasma valproate consentrations are positive relation to blood anmonia consentrations, and are negative relation to serum free carnitine consentration. 43 % of the patients prescribed valproate are below normal carnitien consentration.
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
2013 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 27 Day
Last follow-up date
2018 Year 08 Month 08 Day
Date of closure to data entry
2018 Year 08 Month 08 Day
Date trial data considered complete
2018 Year 08 Month 08 Day
Date analysis concluded
2018 Year 08 Month 08 Day

Other
Other related information Multi facilities cooperation observational, prospective study

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017587


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