UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016362 |
|---|---|
| Receipt number | R000018999 |
| Scientific Title | Effects of OTC switching on prescription trends of ethical drugs |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2018/06/18 19:02:28 |
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Basic information
Public title
Effects of OTC switching on prescription trends of ethical drugs
Acronym
Effects of OTC switching on prescription drugs
Scientific Title
Effects of OTC switching on prescription trends of ethical drugs
Scientific Title:Acronym
Effects of OTC switching on prescription drugs
Region
| Japan |
Condition
Condition
Hay fever, Hyperlipidemia, Pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of OTC switching on prescription trends of original ethical drugs using a nation-wide pharmacy claims database.
Basic objectives2
Others
Basic objectives -Others
Drug utilization
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional, monthly trends in prescription and prescribed patients before and after OTC switching.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients despensed with the study prescription drugs
Key exclusion criteria
Not applicable
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Keio University, Faculty of Pharmacy
Division name
Drug Dev. Regulartory Sci,
Zip code
Address
1-5-30, Shiba-koen, Minato-ku, TOKYO, JAPAN
TEL
+81354002649
urushihara-hs@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keio University |
Organization
Keio University, Faculty of Pharmacy
Division name
Drug Dev. Regulartory Sci,
Zip code
Address
1-5-30, Shiba-koen, Minato-ku, TOKYO, JAPAN
TEL
+81354002649
Homepage URL
urushihara-hs@pha.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
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
| 2015 | Year | 01 | Month | 30 | 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
Results
Manuscript have been developed and publication process ongoing.
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
| 2015 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Drug utilization study using a commercial pharmacy claims database run by IMS Japan, which consists of pharmacy claims data accumulating 53 million prescriptions annually from more than 3000 dispensing pharmacies out-of-hospital beginning from January 2008, accounting for 6.9% of the total national prescriptions.
The study ethical drugs are selected as ones whose OTC-switched drugs started to be sold within the study period and allowing sufficient pre-switching period for evaluating trend changes, including troxipide, loxoprofen sodium hydrate, mequitazine, epinastine hydrochloride, pemirolast, fexofenadine hydrochloride, cetirizine hydrochloride, and ethyl icosapentate.
Management information
Registered date
| 2015 | Year | 01 | Month | 28 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
