Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058623) titled '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' on July 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Graduate School of Health and Welfare, International University of Health and Welfare.
Condition:
Condition - Allergic rhinitis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 22
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 Size - 185
Recruitment Status:
Recruitment status - Preinitiation
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067035
Disclaimer: Curated by HT Syndication.