UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000258 |
|---|---|
| Receipt number | R000000322 |
| Scientific Title | Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism |
| Date of disclosure of the study information | 2005/10/05 |
| Last modified on | 2005/10/15 23:24:15 |
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Basic information
Public title
Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism
Acronym
Effects of octreotide LAR treatment on QOL in acromegalic patients
Scientific Title
Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism
Scientific Title:Acronym
Effects of octreotide LAR treatment on QOL in acromegalic patients
Region
| Japan |
Condition
Condition
acromegaly and pituitary gigantism
Classification by specialty
| Endocrinology and Metabolism | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data will be investigated in patients with acromegaly and pituitary gigantism to whom octreotiede LAR has not been given for recent six months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. QOL(SF-36)
2. Clinical symptom(headache, sweating, arthralgia, carpal-tunnel syndrome, and other clinical symptoms)
3. Serum GH
4. Serum IGF-1
Key secondary outcomes
1. Complication(blood pressure, glucose tolerance status, dyslipidemia, and cardiovascular diseases
2. Adverse events
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
Octreotide LAR 10mg-40mg
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
1) The age is 20 years old or more.
2) Patients diagnosed with acromegaly or pituitary gigantism according to the criteria by
Key exclusion criteria
1) Patients who have previous history of hypersensitivity for elements of Octreotide.
2) Patients whose serum bilirubin or serum creatinine concentration exceeds three times of the upper level of normal ranges.
3) Patients whose AST(GOT) or ALT(GPT) concentration exceeds five times of the upper level of normal ranges.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soji Kasayama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Medicine (Endocrinology and Metabolism)(C-4)
Zip code
Address
2-2 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3831
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soji Kasayama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Medicine (Endaocrinology and Metabolism)(C-4)
Zip code
Address
2-2 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3831
Homepage URL
kasayama@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai Study Groups for Hypothalamic and Pituitary Diseases
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2005 | Year | 10 | Month | 05 | 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
Date of protocol fixation
| 2005 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 10 | Month | 04 | Day |
Last modified on
| 2005 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000322
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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