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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016219
Receipt No. R000018820
Scientific Title The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Date of disclosure of the study information 2015/01/15
Last modified on 2015/01/15

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Basic information
Public title The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Acronym The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Scientific Title The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Scientific Title:Acronym The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Region
Japan

Condition
Condition Secondary adrenal insufficiency
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL, Blood pressure, glucose metabolism, lipid metabolism, bone metabolism
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 10 mg/day
Interventions/Control_2 Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 20 mg/day
Interventions/Control_3 Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 30 mg/day
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 The secondary adrenal insufficiency patient who needs glucocorticoid treatment
Key exclusion criteria Patient who has severe heart failure (NYHA grade 3 or more)
Patient whose serum bilirubin is more than 2.0 mg/dL
Patient whose serum AST or ALT concentration is more than 100 IU/mL
Patient who has malignancy
Patient who has received glucocoriticoids therapy for another diseases
Patient who is unsuitable for this study (Judged by a doctor)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Otsuki
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3732
Email otsuki@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Otsuki
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3732
Homepage URL
Email otsuki@endmet.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Metabolic Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Department of Metabolic Medicine
Organization
Division
Category of Funding Organization
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
2015 Year 01 Month 15 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 Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 15 Day
Last modified on
2015 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018820

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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