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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035909
Receipt No. R000040764
Scientific Title Analysis of vonoprazan efficacy against chronic cough in patients with gastroesophageal reflux disease
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/18

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Basic information
Public title Analysis of vonoprazan efficacy against chronic cough in patients with gastroesophageal reflux disease
Acronym Analysis of vonoprazan efficacy against chronic cough
Scientific Title Analysis of vonoprazan efficacy against chronic cough in patients with gastroesophageal reflux disease
Scientific Title:Acronym Analysis of vonoprazan efficacy against chronic cough
Region
Japan

Condition
Condition Gastroesophageal reflux disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the efficacy of vonoprazan against chronic cough in patients with gastroesophageal reflux disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japan-Leicester Cough Questionnaire at day 28
Key secondary outcomes Cough severity visual analogue scale, FSSG questionnaire and adverse events

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 proton pump inhibitor: vonoprazan
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)chronic non-productive cough
1)presence of heartburn and acid esophagus
2)presence of throat head symptoms such as thrombosis and hoarseness
3)cough worsens with conversation, meal, get up, upper body flexion and weight gain
4)no medications (such as ACE inhibitors) that cause coughing and bronchodilators, inhaled corticosteroids and antiallergic drugs are ineffective
(2)over 20 years old
(3)written consent form
Key exclusion criteria (1)abnormal findings of chest X-ray
(2)history of antacid including proton pump inhibitor
(3)allergy to vonoprazan
(4)anti-Human Immunodeficiency Virus drugs
(5)patients judged inappropriate by physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Nagano
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 0783825660
Email tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Kiriu
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 0783825660
Homepage URL
Email tkiriu@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Organization
Division
Category of Funding Organization Other
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
2019 Year 04 Month 01 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 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
2019 Year 02 Month 18 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040764

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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