UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003127 |
|---|---|
| Receipt number | R000003792 |
| Scientific Title | A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasia |
| Date of disclosure of the study information | 2010/02/15 |
| Last modified on | 2010/02/02 00:53:21 |
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Basic information
Public title
A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasia
Acronym
A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasia
Scientific Title
A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasia
Scientific Title:Acronym
A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasia
Region
| Japan |
Condition
Condition
Functional dyspepsia(FD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to compare the gastric pH between PPI responder and non-responder with FD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the gastric pH pre and post 4 weeks treatment with PPI
Key secondary outcomes
evaluation of the symptom index (GOS scale) pre and post 4 weeks treatment with PPI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole 10 mg before breakfast for 4 weeks
Interventions/Control_2
Rabeprazole 20 mg before breakfast for 4 weeks
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.Diagnosis of Functional Dyspepsia by Rome3 criteria
2. subjects with written informed consent
Key exclusion criteria
1. Organic disease such as reflux esophagitis (> grade A) and erosive gastritis.
2. Patients with past history of gastrectomy
3. NSAIDs or low-dose aspirin -related dyspepsia
4. Patients with organic disease in the brain or with psychological disorders
5. Patients in psychiatric clinic
6.Patients with alcoholics or with drug dependence
7. Severe endocrine disease including hyperthyroidism
8. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases
9. Drug allegy for rabeprazole
10. expectant mother, mother with breast-feeding
11. other not applicable person recognized by a doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
89-1, Enya, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Furuta |
Organization
Shimane University Faculty of Medicine School of Medicine
Division name
Deaprtment of Gastroenterology
Zip code
Address
89-1, Enya, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
Sponsor or person
Institute
FD-pH Society
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Group for FD-pH study
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 | 02 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 02 | Day |
Last modified on
| 2010 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003792
