UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015828 |
|---|---|
| Receipt number | R000018050 |
| Scientific Title | The cough mechanisms due to gastroesophageal reflux disease: relationship between expression of acid and mechanical stress receptor in esophageal mucosa and neurogenic inflammation |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2016/01/06 16:34:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The cough mechanisms due to gastroesophageal reflux disease: relationship between expression of acid and mechanical stress receptor in esophageal mucosa and neurogenic inflammation
Acronym
The cough mechanisms due to gastroesophageal reflux disease
Scientific Title
The cough mechanisms due to gastroesophageal reflux disease: relationship between expression of acid and mechanical stress receptor in esophageal mucosa and neurogenic inflammation
Scientific Title:Acronym
The cough mechanisms due to gastroesophageal reflux disease
Region
| Japan |
Condition
Condition
gastroesophageal reflux-associated chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the expression of TRPV1, TRPV4, ENAC, SP and CGRP and cough in gastroesophageal reflux-associated chronic cough patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the expression level of TRPV1, TRPV4 and ENAC.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression level of TRPV1, TRPV4 and ENAC in esophageal mucosa
Key secondary outcomes
1)Expression level of SP and CGRP in esophageal mucosa.
2)relationship between expression level of TRPV1, TRPV4, ENAC, SP and CGRP and clinical indicators.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Chronic cough group
Patients with persistent cough for 8 weeks or longer and concomitantly having GERD symptom.
2) Control group
Patients with GERD but without cough symptom
Key exclusion criteria
1)patients recieved oral or systemic steroid within one month.
2)patients recieved proton-pomp inhibitor and histamine H2 receptor antagonist within one month.
3)patients having angiotensin converting enzyme inhibitor, anti-leukotriene receptor antagonist and histamine H1 receptor antagonist.
4)patients who are pregnant or possibly pregnant.
5)Patients who are inappropriate to enter this study judged by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Niimi |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address
1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city
TEL
052-851-5511
a.niimi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Takeda |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address
1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city
TEL
052-853-8216
Homepage URL
nori-take-ncu@hotmail.co.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2014 | Year | 12 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | 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
random sample
Management information
Registered date
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018050
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
