UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031360 |
|---|---|
| Receipt number | 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 15:03:44 |
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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
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
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Medical Corporation Shinanokai,
Shinanozaka Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035701
