UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058623 |
|---|---|
| Receipt number | R000067035 |
| Scientific Title | A study on the effect of converting prescription medications to over-the-counter medications (commonly known as Switch OTC) on the willingness of allergic rhinitis patients to choose OTC medications. |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2026/08/09 19:25:02 |
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Basic information
Public title
A study on the effect of switching prescription drugs to over-the-counter drugs (Switch OTC) on the willingness of allergic rhinitis patients to choose OTC medicines.
Acronym
Hereafter referred to as the Switch OTC willingness Study.
Scientific Title
A study on the effect of converting prescription medications to over-the-counter medications (commonly known as Switch OTC) on the willingness of allergic rhinitis patients to choose OTC medications.
Scientific Title:Acronym
Hereafter referred to as the Switch OTC willingness Study.
Region
| Japan |
Condition
Condition
Allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effects of physician-provided information regarding switch OTC drugs and insurer-provided financial incentives (healthcare points) on the willingness of patients with mild allergic rhinitis to choose OTC medications.
Basic objectives2
Others
Basic objectives -Others
The primary purpose of this study is to generate knowledge relevant to healthcare policy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure is the presence or absence of purchase intention for switch OTC products.
as soon as possible.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group 1: No information provided by physicians; cost reduction amount = yen 0 (no discount).
Interventions/Control_2
Group 2: No information provided by physicians; cost reduction amount = yen 1,000.
Interventions/Control_3
Group 3: No information provided by physicians; cost reduction amount = yen 1,500.
Interventions/Control_4
Group 4: Information provided via printed materials; cost reduction amount = yen 0 (no discount).
Interventions/Control_5
Group 5: Information provided via printed materials; cost reduction amount = yen 1,000.
Interventions/Control_6
Group 6: Information provided via printed materials; cost reduction amount = yen 1,500.
Interventions/Control_7
Group 7: Information provided orally by physicians; cost reduction amount = yen 0 (no discount).
Interventions/Control_8
Group 8: Information provided orally by physicians; cost reduction amount = yen 1,000.
Interventions/Control_9
Group 9: Information provided orally by physicians; cost reduction amount = yen 1,500.
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are as follows: patients with a diagnosis of allergic rhinitis in their each medical claim data between January 1 and March 31 of 2024 or 2025, who are undergoing initial treatment, have mild symptoms, and do not meet any exclusion criteria. Written informed consent must be obtained. Eligible participants must be aged between 22 and 64 years at the time of consent, regardless of sex.
Key exclusion criteria
Exclusion criteria are based on the 2024 Guidelines for the Diagnosis and Treatment of Allergic Rhinitis, and include the following: patients with severe or most severe symptoms; patients with moderate symptoms; patients with mild symptoms using additional steroid nasal sprays; patients using medications containing ingredients not available in OTC drugs; and patients using ophthalmic solutions.
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | tai |
| Middle name | |
| Last name | takahashi |
Organization
Graduate School of Health and Welfare, International University of Health and Welfare.
Division name
Department of Healthcare and Welfare Management
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo (Tokyo Akasaka Campus).
TEL
090-2564-4665
tai@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | takamasa |
| Middle name | |
| Last name | ikemoto |
Organization
Graduate School of Health and Welfare, International University of Health and Welfare.
Division name
Department of Healthcare and Welfare Management
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo (Tokyo Akasaka Campus).
TEL
090-2164-4403
Homepage URL
24s3006@g.iuhw.ac.jp
Sponsor or person
Institute
Graduate School of Health and Welfare, International University of Health and Welfare.
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Graduate School of Health and Welfare, International University of Health and Welfare.
Address
4-1-26 Akasaka, Minato-ku, Tokyo (Tokyo Akasaka Campus).
Tel
03-5574-3900
tokyo.s.c@ihwg.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
| 2025 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
306
Results
306 allergic rhinitis patients in a 3x3 factorial design.
[Primary] Chi-square test among 9 groups showed no significant difference (p=0.3967). BH-corrected pairwise comparisons also showed no significance.
[Supplementary] Logistic regression was not overall significant (p=0.0626), but discount was significant (p=0.011). Information provision was non-significant (physician: p=0.394, insurer: p=0.355).
[Conclusion] Higher discounts may increase purchase intention.
Results date posted
| 2026 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics of the 306 analyzed patients with allergic rhinitis were as follows:
- Sex: Male 207 (67.6%), Female 98 (32.0%)
- Age groups: 20s: 29 (9.5%), 30s: 62 (20.3%), 40s: 91 (29.7%), 50s: 117 (38.2%), 60s: 7 (2.3%)
There were no statistically significant imbalances in sex ratio or age distribution among the nine randomized scenario groups, indicating that baseline characteristics were well-balanced across the groups.
Participant flow
Mild allergic rhinitis patients registered in the patient panel of White Healthcare Co., Ltd. were invited to participate. A total of 306 patients who provided informed consent were enrolled.
The 306 enrolled participants were randomized into one of the following nine groups (3 information provision levels x 3 discount levels). All participants completed the online survey and were included in the final analysis (no dropouts or exclusions):
- Group 1 (Physician explanation x 1,500 yen discount): n=30
- Group 2 (Physician explanation x 1,000 yen discount): n=22
- Group 3 (Physician explanation x No discount): n=43
- Group 4 (Insurer notification x 1,500 yen discount): n=43
- Group 5 (Insurer notification x 1,000 yen discount): n=36
- Group 6 (Insurer notification x No discount): n=36
- Group 7 (No information x 1,500 yen discount): n=37
- Group 8 (No information x 1,000 yen discount): n=32
- Group 9 (No information x No discount): n=27
Adverse events
As this study was an online survey assessing purchase intentions using hypothetical scenarios without any actual clinical interventions (such as prescribing or administering medications), no physical or psychological adverse events (including serious adverse events) occurred.
Outcome measures
[Primary Outcome Measure]
The intention to purchase switch OTC drugs instead of prescription medications (binary choice of "Yes" or "No") after scenario presentation.
- Measurement: Self-administered online structured questionnaire.
[Secondary Outcome Measures]
Participants' motivators and barriers for using switch OTC drugs, and their preferred channels for receiving information.
- Measurement: Answers to additional questionnaire items (multiple-choice or free-text format).
Plan to share IPD
no
IPD sharing Plan description
The data analyzed in this study are pseudonymized individual participant data (IPD) derived from an existing patient panel, which was provided free of charge solely for the purpose of this specific research by our collaborating institution, White Healthcare Co., Ltd. Based on the agreement with the collaborating institution and the study protocol approved by the university, there are no plans to disclose, provide, or reuse the IPD externally.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067035
