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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002155
Receipt No. R000002633
Scientific Title Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Date of disclosure of the study information 2009/07/06
Last modified on 2018/09/10

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Basic information
Public title Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Acronym Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Scientific Title Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Scientific Title:Acronym Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Region
Japan

Condition
Condition Postoperative hypoparathyroidism
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of falecalcitriol on hypocalcemia deu to hypoparathyroidism after thyroidectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Serum calcium level
Key secondary outcomes Subjective Symptoms/Safety

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 In the first day after operation, we start administration of falecalcitriol at a dosage of 0.6ug once a day, when below the lower limit of serum calcium. If serum calcium level do not reach normal range, we escalete to 0.9ug/day.Oral calcium lactate is administered 3g/day in all enrolled patients.The dose is reduced when serum calcium and intact PTH level are maintained within normal range. If subjective symptoms such as tetany are worsen up, we start administration of calcium via DIV.
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 The patients whose postoperative serum calcium levels are below lower limit deu to parathyroidectomy in thyroidectomy
Key exclusion criteria 1) Patients with an allergic history of falecalcitoriol
2) Patients who are judged as being unsuitable for the trial by the doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Tanaka
Organization Kawasaki Medical School
Division name Breast and Thyroid Surgery
Zip code
Address 577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email tanakaka@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Tanaka
Organization Kawasaki Medical School
Division name Breast and Thyroid Surgery
Zip code
Address 577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email tanakaka@med.kawasaki-m.ac.jp

Sponsor
Institute kawasaki medicak school
Institute
Department

Funding Source
Organization Kawasaki Medical School, Breast and Thyroid Surgery
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
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
2009 Year 07 Month 06 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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 01 Day
Date of closure to data entry
2018 Year 08 Month 10 Day
Date trial data considered complete
2018 Year 08 Month 10 Day
Date analysis concluded
2018 Year 09 Month 11 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 02 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002633

Research Plan
Registered date File name
2018/09/10 研究計画書2016.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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