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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039344
Receipt No. R000044873
Scientific Title Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients
Date of disclosure of the study information 2020/02/04
Last modified on 2020/02/03

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Basic information
Public title Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients
Acronym Web-based survey of physicians on diagnosis, treatment and underlying diseases in chronic cough
Scientific Title Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients
Scientific Title:Acronym Web-based survey of physicians on diagnosis, treatment and underlying diseases in chronic cough
Region
Japan

Condition
Condition Chronic Cough
Classification by specialty
Medicine in general Chest surgery Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the diagnostic and treatment pathway physicians follow to diagnose and treat chronic cough within the Japanese patient population
To describe the chronic cough patient population from a physician perspective and their complications
To describe characteristics of refractory chronic cough patients and how physicians diagnose and treat refractory chronic cough patients
Basic objectives2 Others
Basic objectives -Others To understand the underlying diseases in the chronic cough, and the diaginosis and treatment.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Diagnosis, treatment pattern, underlying disease information from physicians familiar with chronic cough and refractory chronic cough patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Physicians experienced treating cough as general internal medicine, respiratory or otolaryngology physicians
Physician has treated at least ten adult chronic cough patients in the last 6 months
Key exclusion criteria Physicians employed directly by the pharmaceutical industry
Physicians who undertake individual consulting/advisory roles to the pharmaceutical industry
Physicians previously employed by the pharmaceutical industry
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takekazu
Middle name
Last name Kubo
Organization MSD K. K.
Division name Medical Affairs
Zip code 102-8667
Address KIATNOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, JAPAN
TEL 03-6272-2338
Email takekazu.kubo@merck.com

Public contact
Name of contact person
1st name Takekazu
Middle name
Last name Kubo
Organization MSD K. K.
Division name Medical Affairs
Zip code 102-8667
Address KIATNOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, JAPAN
TEL 03-6272-2338
Homepage URL
Email takekazu.kubo@merck.com

Sponsor
Institute MSD K. K.
Institute
Department

Funding Source
Organization MSD K. K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NA
Name of secondary funder(s) NA

IRB Contact (For public release)
Organization NPO Clinical Research Promotion Network Japan
Address 1-4-9 Noribori, Nishi-ku, Osaka 550-0012, Osaka Prefecture
Tel 0643938403
Email osaka@sct-net.org

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
2020 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 23 Day
Date of IRB
2020 Year 01 Month 23 Day
Anticipated trial start date
2020 Year 03 Month 31 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
2020 Year 04 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 05 Day
Date analysis concluded
2020 Year 06 Month 05 Day

Other
Other related information NA

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2020 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044873

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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