UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of OTC switching on prescription trends of ethical drugs
Title of the study (Brief title)	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	Hisashi Urushihara
Organization	Keio University, Faculty of Pharmacy
Division name	Drug Dev. Regulartory Sci,
Address	1-5-30, Shiba-koen, Minato-ku, TOKYO, JAPAN
TEL	+81354002649
Email	urushihara-hs@pha.keio.ac.jp

Public contact
Name of contact person	Keio University
Organization	Keio University, Faculty of Pharmacy
Division name	Drug Dev. Regulartory Sci,
Address	1-5-30, Shiba-koen, Minato-ku, TOKYO, JAPAN
TEL	+81354002649
Homepage URL
Email	urushihara-hs@pha.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Manuscript have been developed and publication process ongoing.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018999