UMIN-CTR Clinical Trial

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 Tatsuya Middle name Last name Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	6500017
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 Tatsunori Middle name Last name Kiriu
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	6500017
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	Kobe University Hospital Clinical Translational Research Center
Address	7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
Tel	0783826669
Email	chiken@med.kobe-u.ac.jp

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	Completed
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 01 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2020 Year 08 Month 28 Day
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	2021 Year 08 Month 21 Day

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