UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014500 |
|---|---|
| Receipt number | 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 09:04:14 |
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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
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
otsuki@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016868
