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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010803
Receipt No. 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

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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
Email 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
Email bk2m-cbi@asahi-net.or.jp

Sponsor
Institute Heiwadai clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012618

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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