UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005271 |
|---|---|
| Receipt number | R000006267 |
| Scientific Title | A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) - Prospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis - |
| Date of disclosure of the study information | 2011/03/18 |
| Last modified on | 2014/04/02 22:05:20 |
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Basic information
Public title
A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
- Prospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis -
Acronym
A prospective 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)
- Prospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis -
Scientific Title:Acronym
A prospective 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 the healing rate after oral PPI therapy in patients with esophageal endoscopic findings consistent with Grade C or D reflux esophagitis according to the modified Los Angeles classification (LA classification)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Esophageal endoscopic findings according to the LA classification
Key secondary outcomes
- Frequency and severity of acid reflux-related symptoms (heartburn, acid regurgitation) and dyspepsia-related symptoms (heavy stomach feeling, early satiety, epigastralgia, epigastric burning sensation)
- Factors that may affect healing of lesions
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
1) Patients who have provided written consent of their own free will to participate in the study after receiving sufficient written and verbal information about the study
2) Patients of both sexes aged 20 years or above.
3) Patients endoscopically diagnosed with Grade C or D reflux esophagitis according to the LA classification
Key exclusion criteria
1) Patients with a history of gastrointestinal resection or vagotomy
2) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss
3) Patients with concurrent peptic ulcer (not in the scarring stage)
4) Patients with a prior or current history of any of the following diseases:
- Zollinger-Ellison syndrome
- Inflammatory bowel disease (IBD)
- Irritable bowel syndrome (IBS)
- Esophageal stricture
- Eosinophilic reflux esophagitis
- Esophageal achalasia
- Malabsorption
- Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction
5) Patients complicated by serious hepatic, renal, cardiac, or other diseases for which the participation in the study would be difficult
6) Patients with a confirmed or suspected malignant lesion
7) Patients who are pregnant, breastfeeding, or may be pregnant
8) Patients considered to require continued use of any drugs that could interact with the study drugs (i.e., atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, antacids containing aluminium hydroxide gel and magnesium hydroxide, and clopidogrel)
9) Patients with a history of hypersensitivity to any components of proton pump inhibitor products
10) Patients who received a proton pump inhibitor within a week prior to endoscopy
11) Other patients judged by the physician to be inappropriate for this study
Target sample size
120
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
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 | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
A prospective nonrandomized multicenter observational study.
To determine the healing rate after oral PPI therapy in patients with esophageal endoscopic findings consistent with Grade C or D reflux esophagitis according to the modified Los Angeles classification (LA classification)
1) Drugs for PPI therapy
Omeprazole tablet 20mg
Lansoprazole Capsule or OD tablet 30mg
Rabeprazole tablet 10mg or 20mg
2) Administration
Once daily oral administration
3) Administration period
8 weeks
Management information
Registered date
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2014 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006267
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