UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001974 |
|---|---|
| Receipt number | R000002387 |
| Scientific Title | A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole |
| Date of disclosure of the study information | 2009/05/20 |
| Last modified on | 2019/12/04 22:03:18 |
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Basic information
Public title
A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole
Acronym
DMETS study
Scientific Title
A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole
Scientific Title:Acronym
DMETS study
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of omeprazole in functional dyspepsia with or without metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of dyspeptic symtoms by Gastrointestinal Symptom Rating Scale(GSRS)
Key secondary outcomes
Patients' Background
QOL evaluation by SF-36
Anti-H. pylori IgG
Serum pepsinogen I, pepsinogen II
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
omeprazole
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
Patients with functional dyspepsia diagnosed according to the Rome III classification.
Key exclusion criteria
1. Endoscopic finding 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 treated with proton pump inhibitors(PPI), H2 receptor antagonists(H2RAs), prokinetic drugs, anticholinergic drugs, antidepressant drugs, antianxiety drugs (within 14 days prior to the screening visit)
5. Patients with organic disease in the brain or with psychological disorders
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 omeprazole
10. Expectant mother, mother with breast-feeding
11. Other not applicable patients recognized by a doctor
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | MAMORU |
| Middle name | |
| Last name | ITO, M.D., Ph.D. |
Organization
Okayama Saiseikai General Hospital
Division name
Internal Medicine
Zip code
700-0021
Address
2-25 Kokutaicho, Kita-Ku, Okayama 700-0021, JAPAN
TEL
086-252-2211
mitohxxx@gmail.com
Public contact
Name of contact person
| 1st name | MAMORU |
| Middle name | |
| Last name | ITO, M.D., Ph.D. |
Organization
Okayama Saiseikai General Hospital
Division name
Internal Medicine
Zip code
700-0021
Address
2-25 Kokutaicho, Kita-Ku, Okayama 700-0021, JAPAN
TEL
086-252-2211
Homepage URL
mitohxxx@gmail.com
Sponsor or person
Institute
Office of DMETS study
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Saiseikai General Hospital Institutional Review Board
Address
2-25 Kokutaicho, Kita-Ku, Okayama 700-0021, JAPAN
Tel
086-252-2211
chiken-hp@okayamasaiseikai.or.jp
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
| 2009 | Year | 05 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002387
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
