UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035909 |
|---|---|
| Receipt number | 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 | 2021/08/21 13:13:51 |
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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 | 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
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
tkiriu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040764
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
