UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032810 |
|---|---|
| Receipt number | R000037422 |
| Scientific Title | Large-scale database study using pharmacy receipt data on usage conditions of the existing oral analgesic agent |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/08/30 14:26:00 |
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Basic information
Public title
Large-scale database study using pharmacy receipt data on usage conditions of the existing oral analgesic agent
Acronym
Database study on oral analgesic agent
Scientific Title
Large-scale database study using pharmacy receipt data on usage conditions of the existing oral analgesic agent
Scientific Title:Acronym
Database study on oral analgesic agent
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey on the actual prescriptions in patients who newly received the oral analgesic drug
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of patients receiving oral analgesics
Key secondary outcomes
1) Usage ratio of oral analgesics
2) Prescription dose of oral analgesics (Total dose, mean dose, etc.)
3) Ratio according to the combination prescription pattern of oral analgesics
4) Distribution of the starting doses of oral analgesics, dose change by starting dose, starting doses maintenance period
5) Maintenance dose of oral analgesics, distribution of the arrival dose
6) The prescription period and MPR of oral analgesics
7) Stopping dosage ratio of oral analgesics
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients in whom an oral analgesic was newly prescribed in Japan from January 1, 2017 to December 31, 2017.
Key exclusion criteria
An oral analgesic is prescribed within 180 days before the first prescription day.
Target sample size
6700000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Okuizumi |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Medical Science Department
Zip code
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL
03-6225-1053
okuizumi.kaoru.tr@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiju Matsui |
Organization
DAIICHI SANKYO CO., LTD
Division name
Medical Science Department
Zip code
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL
03-6225-1053
Homepage URL
Matsui.daiju.ks@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
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
Address
Tel
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
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/14656566.2019.1651840
Number of participants that the trial has enrolled
2042302
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
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database study on oral analgesic agent.
This is a study that has not been deliberated by the Ethics Review Committee.
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
