UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Title of the study (Brief title)	Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Region	Japan

Condition
Condition	Seasonal allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the treatment satisfaction on rupatadine therapy in patients with seasonal allergic rhinitis who were dissatisfied with other antihistamine drugs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment satisfaction of the patient on the 11th day
Key secondary outcomes	1) Total nasal symptom score 2) Night nasal congestion score 3) QOL score

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rupatadine 10mg per day for 10 days Add another rupatadine 10mg from the 6th day if the patient is not satisfied with the treatment.
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) At the time of the agreement 1) Males and females aged 20-59 years. 2) Patient who has allergic symptoms during Japanese cedar pollen season for at least the past two years. 3) Patient who is dissatisfied with anti-histamine treatment in the last year. 4) Written informed consent is required. (2) At the time of the registration 1) Patients with positive specific IgE antibody for Japanese cedar pollen. 2) Patient who has 4 nasal symptoms (sneezing, nasal discharge, nasal obsrtuction, and nasal itching), and total nasal symptom score (the sum of each nasal symptom score) is more than 6 in average (18 points in total) three days before treatment. 3) Patient who is dissatisfied with symptoms of seasonal allergic rhinitis at the start of the study. 4) Patient who can fill in a patient diary adequately and exactly.
Key exclusion criteria	1) Patient with nasal disorders and/or infectious diseases. 2) Patient with non-allergic rhinitis. 3) Patient who underwent nasal surgery, including laser or coagulation surgery to improve nasal symptoms for less than one year before the agreement. 4) Patient with uncontrolled asthma. 5) Patient who has the hypersensitivity to antihistamine including rupatadine. 6) Following medications and treatments are prohibited before the start of the study. Antihistamine, leukotriene receptor antagonist, anti-thromboxane A2, and any antirhinitis medications. Steroid preparation (oral, injection, inhalation, and nasal drop), vasoconstictor (eye or nasal drop), parasympathetic nerve blocker (anti-cholinergic drug), biological preparation, immunosuppressive drug and any other drugs with similar pharmacological properties (eg Chinese herbal medicine), laser surgery, coagulation surgery, and nasal irrigation with normal saline. 7) Patient who is undergoing immunotherapy. 8) Patient with a liver or renal dysfunction. 9) Patient with severe complications. 10)Pregnant women or breast-feeding women, and patients who may be pregnant. 11) Patient who is judged to be ineligible for participation in the study by the clinical investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuhiro Hashiguchi
Organization	Medical Corporation Shinanokai, Shinanozaka Clinic
Division name	Department of Otorhinolaryngology
Address	Yotsuya-Medical-bldg.3F, 20,Samoncho,Shinjuku-ku, Tokyo,Japan,160-0017
TEL	03-5366-3006
Email	k_hashiguchiiii@yahoo.co.jp

Public contact
Name of contact person	Satoko Shimizu
Organization	Tokyo Research Center of Clinical Pharmacology co.,ltd
Division name	Clinical trial promotion II dept.
Address	Yotsuya-Medical-bldg.6F, 20,Samoncho,Shinjuku-ku, Tokyo,Japan,160-0017
TEL	03-5366-3454
Homepage URL
Email	s-shimizu@trcp.co.jp

Sponsor
Institute	Medical Corporation Shinanokai, Shinanozaka Clinic
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation Teikoku Seiyaku co.,ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 02 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.iyaku-j.com/iyakuj/system/M2-1/summary_viewer.php?trgid=34981
Results
Other related information

Management information
Registered date	2018 Year 02 Month 19 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035701