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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012827
Receipt No. R000014984
Scientific Title Efficacy of Helicobacter pylori eradication followed by sequential administration of proton pump inhibitor and proton pump inhibitor plus prokinetic for the patients with dyspepsia
Date of disclosure of the study information 2014/01/14
Last modified on 2014/01/11

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Basic information
Public title Efficacy of Helicobacter pylori eradication followed by sequential administration of proton pump inhibitor and proton pump inhibitor plus prokinetic for the patients with dyspepsia
Acronym Efficacy of H.pylori eradication, PPI, and PPI plus prokinetic for dyspepsia
Scientific Title Efficacy of Helicobacter pylori eradication followed by sequential administration of proton pump inhibitor and proton pump inhibitor plus prokinetic for the patients with dyspepsia
Scientific Title:Acronym Efficacy of H.pylori eradication, PPI, and PPI plus prokinetic for dyspepsia
Region
Japan

Condition
Condition patients with dyspepsia and H.pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the symptom relief by the sequential treatment: H.pylori eradication; proton pump inhibitor; and proton pump inhibitor plus prolinetic for the patients with dyspepsia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) overall evaluation for each treatment by patients
2) evaluation of symptom index (modified F scale)
at baseline, post 4 weeks treatment of rabeprazole, and post 4 weeks treatment of rabeprazole plus acotiamide
Key secondary outcomes 1) assessment of the symptom factors that influence the efficacy during the treatment from the symptom index (modified F scale)
2) patients'QOL by using SF 8 scale
at baseline, post 4 weeks treatment of rabeprazole, and post 4 weeks treatment of rabeprazole plus acotiamide

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) the subjects complaining of dyspepsia with gastritis diagnosed by EGD and H.pylori infection
2) the subjects with written informed consent
Key exclusion criteria 1) patients with past history of gastrectomy
2) patients with alarm symptom auch as vomiting, gastrointestinal hemorrhage, and rapid body weight loss
3) reflux esophagitis (> and = Los Angeles grade A) or peptic ulcer
4) patients with the following diseases or previous history: Zollinger-Ellison syndrome; inflammatory bowel disease; esophageal stenosis; Achalasia; and organic disease in the brain
5) severe diseases in liver, kidney, and heart
6) persons with malignancy or possibility of malignancy
7) expect muther, mother with breast-feeding
8) under administration of atazanavir sulfate
9) drug allegy for penicillin
10) administration the following drugs within 2 weeks: proton pump inhibitors; histamine 2-receptor antagonists; and prokinetics
11) other not applicable person recognized by a doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL 086-235-7218
Email hiro@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL 086-235-7218
Homepage URL
Email hiro@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Okayama GUT study group (O-GUTs)
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 14 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
2013 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 14 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information evaluation of the efficacy of the following sequential treatment: H.pylori eradication; administration of rabeprazole; admonostration of rabeprazole plus acothiamid as follows.
1) overall evaluation for each treatment by patients
2) evaluation of symptom index (modified F scale)
at baseline, post 4 weeks treatment of rabeprazole, and post 4 weeks treatment of rabeprazole plus acotiamide

Management information
Registered date
2014 Year 01 Month 11 Day
Last modified on
2014 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014984

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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