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

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 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


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

Value
https://center6.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