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Recruitment status Terminated
Unique ID issued by UMIN UMIN000014500
Receipt No. R000016868
Scientific Title The dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Date of disclosure of the study information 2014/07/07
Last modified on 2019/01/09

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Basic information
Public title The dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Acronym The dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Scientific Title The dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Scientific Title:Acronym The dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Region
Japan

Condition
Condition Acromegaly
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the dose fluctuation effect of octoreotide LAR on the endocrine features and clinical symptoms in acromegalic patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Growth hormone, Insulin-like growth factor-1
Key secondary outcomes QOL, clinical symptom, complication

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 Duration 1 year
Subject acromegaly
Drug therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient who is diagnosed acromegaly using "The clinical guideline of diagnosis and treatment in acromegaly" made by the research group of hypothalamohypophysial disease of Ministry of Health, Labour and Welfare in Japan
Patient who has poor growth hormone control
Key exclusion criteria Patient whom octoreotide LAR is contraindicated for
Patient whose serum bilirubin or creatinine concentration is more than three fold above its upper normal range
Patient whose serum AST or ALT concentration is more than five fold above its upper normal range
Patient who has malignancy
Patient who has received radiation therapy for pituitary within 10 years
Patient who is unsuitable for this study (Judged by a doctor)
Target sample size 30

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 SCCRE the research group of Kansai diencephalohypophysial diseases
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 07 Month 07 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 Terminated
Date of protocol fixation
2014 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 24 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
2014 Year 07 Month 07 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016868

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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