UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005272 |
|---|---|
| Receipt number | R000006269 |
| Scientific Title | A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) - Retrospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis - |
| Date of disclosure of the study information | 2011/03/18 |
| Last modified on | 2011/08/29 17:22:55 |
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Basic information
Public title
A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
- Retrospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis -
Acronym
A retrospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
Scientific Title
A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
- Retrospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis -
Scientific Title:Acronym
A retrospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine any Grade A to D esophageal erosions according to the modified Los Angeles classification (LA classification) retrospectively based on a review of medical records of patients with reflux esophagitis treated with a proton pump inhibitor (PPI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Esophageal endoscopic findings after at least eight weeks of treatment with any of the drugs surveyed
Key secondary outcomes
Factors that may affect cure of lesions (e.g., sex, age, BMI, duration of disease, LA grade, acid reflux-related symptoms, H. pylori, PPI dose)
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
To be eligible for this study, patients must have undergone endoscopy between August 2005 and July 2010, meet all of the following inclusion criteria, and not meet any of the key exclusion criteria:
- Patients of both sexes aged 20 years and above
- Patients who received eight-week or longer treatment with any of the designated PPIs (i.e., drugs surveyed) of omeprazole, lansoprazole, or rabeprazole
- Patients with endoscopically confirmed Grade A or worse reflux esophagitis according to the LA classification within four weeks before PPI therapy
- Patients who underwent endoscopy after at least eight weeks of PPI therapy, for whom records are available on findings according to the LA classification. The endoscopic findings must have been obtained from endoscopy conducted during PPI therapy or within four weeks after the end of PPI therapy.
Key exclusion criteria
1) Patients who had a history of gastrointestinal resection or vagotomy
2) Patients who had a concurrent malignant lesion
3) Patients who had a prior or current history of any of the following diseases:
- Esophageal stricture
- Eosinophilic reflux esophagitis
- Esophageal achalasia
- Malabsorption
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Haruma |
Organization
Kawasaki Medical School
Division name
Gastroenterology, Ultrasonography, and Translational Medicine & Nutrition
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
GERD Society
Division name
Secretariat
Zip code
Address
TEL
Homepage URL
gerd@mcp.co.jp
Sponsor or person
Institute
GERD Society
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
川崎医科大学（岡山県） 他51施設（予定）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
A multicenter prospective survey
1) Survey drugs
Omeprazole tablet 20mg or 10mg
Lansoprazole Capsule or OD tablet 15mg or 30mg
Rabeprazole tablet 10mg or 20mg
2) Survey records
Medical redords containing at least two endoscopic results obtained between August 2005 and July 2010
Management information
Registered date
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2011 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006269
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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