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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031360
Receipt No. R000035701
Scientific Title Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Date of disclosure of the study information 2018/02/19
Last modified on 2018/10/25

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Basic information
Public title Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Acronym Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Scientific Title Evaluation of the clinical usefulness of rupatadine in patients with seasonal allergic rhinitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiro Hashiguchi
Organization Medical Corporation Shinanokai,
Shinanozaka Clinic
Division name Department of Otorhinolaryngology
Zip code
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
1st name
Middle name
Last name Satoko Shimizu
Organization Tokyo Research Center of Clinical Pharmacology co.,ltd
Division name Clinical trial promotion II dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.iyaku-j.com/iyakuj/system/M2-1/summary_viewer.php?trgid=34981
Number of participants that the trial has enrolled
Results
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
2018 Year 02 Month 02 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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