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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005272
Receipt No. 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

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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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization GERD Society
Division name Secretariat
Zip code
Address
TEL
Homepage URL
Email gerd@mcp.co.jp

Sponsor
Institute GERD Society
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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