UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055140 |
|---|---|
| Receipt number | R000062994 |
| Scientific Title | Trends in Syphilis Treatments and the Impact of Intramuscular Injectable Benzathine Penicillin G in Japan |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2024/08/02 10:27:57 |
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Basic information
Public title
Trends in Syphilis Treatments and the Impact of Intramuscular Injectable Benzathine Penicillin G in Japan
Acronym
Trends in Syphilis Treatments and the Impact of Intramuscular Injectable Benzathine Penicillin G in Japan
Scientific Title
Trends in Syphilis Treatments and the Impact of Intramuscular Injectable Benzathine Penicillin G in Japan
Scientific Title:Acronym
Trends in Syphilis Treatments and the Impact of Intramuscular Injectable Benzathine Penicillin G in Japan
Region
| Japan |
Condition
Condition
Syphilis
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current status of syphilis treatment and to grasp the prescription status of Intramuscular Injectable Benzathine Penicillin G.
Basic objectives2
Others
Basic objectives -Others
Drug utilization research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prescription status of Intramuscular Injectable Benzathine Penicillin G.
Key secondary outcomes
Syphilis treatment antibiotics prescription status.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 15 years or older.
Patients were diagnosed of syphilis.
Patients were prescribed antibiotics for syphilis treatment.
Key exclusion criteria
Patients who had undergone surgery, blood transfusion, gastrointestinal endoscopy, or coronary angiography in the index month.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Shoji |
Organization
University of Yamanashi Hospital
Division name
Department of Pharmacy
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
+81-55-273-1111
tshohji@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Shoji |
Organization
University of Yamanashi Hospital
Division name
Department of Pharmacy
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
+81-55-273-1111
Homepage URL
tshohji@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi Hospital
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Healthcare Data Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Ethics Committee
Address
1110, Shimokato, Chuo, Yamanashi
Tel
+81-55-273-1111
rec-med@yamanashi.ac.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
| 2024 | Year | 08 | Month | 02 | 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
3000
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is retrospective.
This study is cohort sample.
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062994
