UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012827 |
|---|---|
| Receipt number | 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 17:31:25 |
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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
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
hiro@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014984
| Research Plan | |
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| 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 |
