UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010803 |
|---|---|
| Receipt number | R000012618 |
| Scientific Title | A stydy to evaluate the efficacy of EAC-EAM regimen for Helicobacter pylori eradication. |
| Date of disclosure of the study information | 2013/05/25 |
| Last modified on | 2015/09/07 13:57:59 |
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Basic information
Public title
A stydy to evaluate the efficacy of EAC-EAM regimen for Helicobacter pylori eradication.
Acronym
A stydy to evaluate the efficacy of EAC-EAM regimen for HP eradication.
Scientific Title
A stydy to evaluate the efficacy of EAC-EAM regimen for Helicobacter pylori eradication.
Scientific Title:Acronym
A stydy to evaluate the efficacy of EAC-EAM regimen for HP eradication.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the overall H.pylori eradication rate in oreder to evaluate the efficacy of the primary eradication regimen and the secondary eradication regimen in the patients who are eligible for H,pylori eradication therapy in the range covered by health insurance. As the second objectives, primary and secondary eradication rate by each regimen, and the factors that affect eradication rate including CAM-resistance, CYP2C19 genotype, are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The overall eradication rate
Key secondary outcomes
H,pylori eradication rate by each regimen.
H,pylori eradication rate by each factor including CYP2C19 genotype, drug-resistant bacteria, and any other backgrounds.
Safety will be investigated on the basis of evaluation of adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Primary eradication therapy:Three drugs,i.e.,esomeprazole 20mg, amoxicillin 750mg, and clarithromycin 200mg, will be simultaneously administered twice daily for 7days.
Secondary eradication therapy:Three drugs,i.e.,esomeprazole 20mg, amoxicillin 750mgmg, and metronidazole 250mg, will be simultaneously administered twice daily for 7days.
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) Patients in whom H.pylori infection has been confirmed by serum anti-H.pylori antibody test or rapid urease test, and cultural method.
2) Patients who fall under at least one of the following matters.
Patients with a history of gastric ulcer or duodenal ulcer.
Patients with gastric MALT lymphoma.
Patients with idiopathic thrombocytopenic purpura.
Patients after endoscopic treatment of early-stage gastric cancer.
Patients with H.pylori-induced gastritis.
Key exclusion criteria
1) Patients with symptoms of hypersensitivity to the study drugs.
2) Patients with a history of H.pylori eradication.
3) Patients with a history of resection of gastrointestinal tract or vagal neurotomy.
4) Patients having peptic ulcer of stages other than the scarred stage as a complication.
5) Patients with warning findings such as vomiting and sudden weight loss.
6) Patients for whom participation in this study is difficult becaese of such complication as serious hepatic disease, renal disease, or cardiac disease.
7) Patients who have received PPI, histamin H2 receptor antagonist, selective muscarine receptor antagonist, anticholinergic drug, antacid, prostaglandin preparation, drug for reinforcing gastric mucosa protection factor, and bismuth preparation within 2 weeks before the diagnosis of H.pylori infection.
8) Women hwo are pregnant, lactating or who may be pregnant.
9) Patients for whom administration of any of following drugs is necessary.
Atazanavir sulfate, pimozide, ergotamine or preparation containing ergotamine, tadalafil, SU, and colchicine.
10) Patients who are deemed ineligible as the subjects of study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyasu Chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
bk2m-cbi@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyasu Chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
Homepage URL
bk2m-cbi@asahi-net.or.jp
Sponsor or person
Institute
Heiwadai clinic
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
平和台クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012618
