UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044105 |
|---|---|
| Receipt number | R000048966 |
| Scientific Title | status of usage of olanzapine in patients with malignancies at our hospital |
| Date of disclosure of the study information | 2021/05/05 |
| Last modified on | 2021/11/03 15:12:33 |
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Basic information
Public title
status of usage of olanzapine in patients with malignancies at our hospital
Acronym
status of usage of olanzapine in patients with malignancies at our hospital
Scientific Title
status of usage of olanzapine in patients with malignancies at our hospital
Scientific Title:Acronym
status of usage of olanzapine in patients with malignancies at our hospital
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To understand the purpose, effects, and adverse events of olanzapine in patients with malignancies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate of symptom relief with olanzapine for each symptom
Key secondary outcomes
Duration of prescription, reason for stopping prescription, number of days alive or days to end of treatment after starting, side effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant tumor disease who received a prescription for olanzapine at Kanto Central Hospital of the Public School Mutual Aid Association between 2008, when olanzapine was launched, and May 2020.
Key exclusion criteria
Those who were prescribed the drug to treat comorbidities unrelated to malignancy. Those who refused to participate in the study by opting out.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Kanto Central Hospital of the Mutual Aid Association School of Teachers
Division name
Respiratory Medicine
Zip code
158-8531
Address
6-25-1 Kamiyoga, Setagaya-ku, Tokyo
TEL
03-3429-1171
nnakagawautmedsle@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Kanto Central Hospital of the Mutual Aid Association School of Teachers
Division name
Respiratory Medicine
Zip code
158-8531
Address
6-25-1 Kamiyoga, Setagaya-ku, Tokyo
TEL
03-3429-1171
Homepage URL
https://www.kanto-ctr-hsp.com
nnakagawautmedsle@yahoo.co.jp
Sponsor or person
Institute
Kanto Central Hospital of the Mutual Aid Association School of Teachers (Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
Kanto Central Hospital of the Mutual Aid Association School of Teachers (Clinical Research Center)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto Central Hospital of the Mutual Aid Association School of Teachers
Address
6-25-1 Kamiyoga, Setagaya-ku, Tokyo
Tel
03-3429-1171
nnakagawautmedsle@yahoo.co.jp
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
| 2021 | Year | 05 | 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
41
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 15 | Day |
Other
Other related information
Using the electronic medical record database, patients who met the inclusion criteria were comprehensively searched and those who met the exclusion criteria were excluded, and the following data were extracted.
The following data were extracted.
-age, sex, name of malignant tumor causing symptoms, presence or absence and location of distant metastasis, and presence or absence of surgery, radiation therapy, or drug therapy for malignant tumor.
-The symptoms that led to the prescription of olanzapine or Zyprexa, and changes in these symptoms over time after the prescription.
-The presence or absence of chemotherapy at the time of prescription.
-The duration of prescription, reason for discontinuing prescription, and any possible side effects.
-The duration of the prescription, the reason for stopping the prescription, and the number of days the patient has survived since starting the drug or the number of days until the end of the diagnosis.
Management information
Registered date
| 2021 | Year | 05 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048966
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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