UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044326 |
|---|---|
| Receipt number | R000050628 |
| Scientific Title | Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug. |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2021/05/25 19:59:45 |
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Basic information
Public title
Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Acronym
Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Scientific Title
Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Scientific Title:Acronym
Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Region
| Japan |
Condition
Condition
Malignant glioma
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compariozon of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL:EORTC QLQ-C308
Anolexia:Numerical Rating Scale
Change of body weight, before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olanzapine
Interventions/Control_2
Rikkunshito
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
1)Patient of malignant glioma
Key exclusion criteria
1)Deep coma
2)Uncontrollable Diabetes mellitus
3)Heavy liver dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Katayama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of neurosurgery
Zip code
036-8562
Address
Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
TEL
+81-172-39-5115
k.kosuke@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Katayama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of neurosurgery
Zip code
036-8562
Address
Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
TEL
+81-172-39-5115
Homepage URL
k.kosuke@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
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
crb-hirosaki
Address
Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
Tel
+81-172-39-5362
crb-hirosaki@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
17R01001
Org. issuing International ID_1
17R01001
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 26 | 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
| 2019 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050628
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
