UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043605 |
|---|---|
| Receipt number | R000049786 |
| Scientific Title | Adverse drug reaction and impact of it of pulmonary tuberculosis treatment. |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2022/09/14 20:10:53 |
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Basic information
Public title
Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Acronym
Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Scientific Title
Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Scientific Title:Acronym
Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Region
| Japan |
Condition
Condition
pulmonary tuberculosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We mainly evaluate the difference of incidence of adverse drug reaction that requires discontinuation or change of medication by age and the discontinuation period.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of the incidence of adverse drug reaction that requires discontinuation or change of medication (dADR) by age among patients aged 50 or older.
Key secondary outcomes
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
| 22 | years-old | <= |
Age-upper limit
| 98 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who started pulmonary tuberculosis treatment at our hospital from April 2018 to March 2020.
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kaki |
Organization
National Hospital Organization Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL
0738-22-3256
tk-3155kaki.xd7@nifty.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kaki |
Organization
National Hospital Organization Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL
0738-22-3256
Homepage URL
tk-3155kaki.xd7@nifty.com
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
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
National Hospital Organization Wakayama Hospital Ethics Committee
Address
1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
Tel
0738-22-3256
419-kenkyubu@mail.hosp.go.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 | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study was conducted based on medical records.
Management information
Registered date
| 2021 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049786
| 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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| Registered date | File name |
