UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004407 |
|---|---|
| Receipt number | R000005267 |
| Scientific Title | A study on the prevalence of gastroesophageous reflex disease(GERD) included in non-cardiac chest pain(NCCP). (observational study) |
| Date of disclosure of the study information | 2010/10/18 |
| Last modified on | 2014/08/06 10:16:20 |
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Basic information
Public title
A study on the prevalence of gastroesophageous reflex disease(GERD) included in non-cardiac chest pain(NCCP). (observational study)
Acronym
A study on the prevalence of GERD included in NCCP.
Scientific Title
A study on the prevalence of gastroesophageous reflex disease(GERD) included in non-cardiac chest pain(NCCP). (observational study)
Scientific Title:Acronym
A study on the prevalence of GERD included in NCCP.
Region
| Japan |
Condition
Condition
The patients of NCCP caused by GERD.
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will develop the prevalence of GERD in patients with NCCP.
Basic objectives2
Others
Basic objectives -Others
This study will develop the pathophysiology of NCCP caused by esophagus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Upper gastrointestinal endoscopy
2. Esophageal manometry
3. 24h impedance and pH monitoring
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients diagnosed with NCCP by cardiovascular specialist
Key exclusion criteria
1. The patients have had a drug allergy to hydrochloride or local anesthetics with anilide.
2. The patients have had esophagectomy, gstrectomy or vagotomy.
3. The patients have been returned unfit for this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
89-1, tyou-enya, shi-izumo, shimane prefecture
TEL
0853-20-2190
shimurashino@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
89-1, tyou-enya, shi-izumo, shimane prefecture
TEL
0853-23-2190
Homepage URL
shimurashino@yahoo.co.jp
Sponsor or person
Institute
University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University Faculty of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2010 | Year | 10 | Month | 18 | 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
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
This study is prospective study.
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2014 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005267
