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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001974
Receipt No. 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 2019/05/24

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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
Email 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
Email mitohxxx@gmail.com

Sponsor
Institute Office of DMETS study
Institute
Department

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
Email 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 Open public 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 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002387

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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