UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042166 |
|---|---|
| Receipt number | R000048131 |
| Scientific Title | A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity. |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2020/10/19 15:52:12 |
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Basic information
Public title
A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Acronym
A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Scientific Title
A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Scientific Title:Acronym
A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study scientifically proves whether there is a difference in the patient's awareness of compliance regardless of the confirmation period of the "periodic confirmation form" and considers a more appropriate drug safety management procedure. Since the introduction of drug safety management procedures, while safety has been emphasized, we will study the ideal way of appropriate drug safety management procedures for reducing the burden on patients in cluster randomized trials, which have not been done so far.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation that all subjects and their partners do not report pregnancy
Percentage of correct answers (correct answers to all questions of questionnaire 7 questions) of the understanding questionnaire (Appendix) at 24 weeks
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
Understanding the Noveltability of Thalidmid(Non-extended groups)
Interventions/Control_2
Understanding the Noveltability of Thalidmid(extended groups)
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
Men over 20 years of age and pregnant women treating thalidmid drugs in patients with multiple myeloma
Key exclusion criteria
Female patients with no possibility of pregnancy
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | kenshi |
| Middle name | |
| Last name | suzuki |
Organization
Japanese Red Cross Medical Center
Division name
Myeloma Amyloidosis Center
Zip code
1508935
Address
Hiroo 4-1-22, Shibuya-ku, Tokyo
TEL
03-3400-1311
ken-suzuki@mtb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | rena |
| Middle name | |
| Last name | tazawa |
Organization
Japanese Red Cross Medical Center
Division name
Medical Secretary's Division
Zip code
1508935
Address
Hiroo 4-1-22, Shibuya-ku, Tokyo
TEL
03-3400-1311
Homepage URL
iryohisyoka2@med.jrc.or.jp
Sponsor or person
Institute
Ministry of Health, Labou Safety Measures Section
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Medical Center
Address
Hiroo 4-1-22, Shibuya-ku, Tokyo
Tel
03-3400-1311
ken-suzuki@mtb.biglobe.ne.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
| 2020 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
900
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
| 2020 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048131
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
