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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007733
Receipt No. R000009035
Scientific Title Helicobacter pylori eradication one-week triple therapy with esomeprazole versus lansoprazole, amoxicillin and clarithromycin: a randomized, open-label, non-inferiority trial.
Date of disclosure of the study information 2012/04/13
Last modified on 2014/04/22

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Basic information
Public title Helicobacter pylori eradication one-week triple therapy with esomeprazole versus lansoprazole, amoxicillin and clarithromycin: a randomized, open-label, non-inferiority trial.
Acronym Helicobacter pylori eradication one-week triple therapy with esomeprazole, amoxicillin and clarithromycin
Scientific Title Helicobacter pylori eradication one-week triple therapy with esomeprazole versus lansoprazole, amoxicillin and clarithromycin: a randomized, open-label, non-inferiority trial.
Scientific Title:Acronym Helicobacter pylori eradication one-week triple therapy with esomeprazole, amoxicillin and clarithromycin
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine an efficacy and safety of esomeprazole based triple therapy as the first-line treatment for patients with H.pylori.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Non-inferiority trial of the eradication rate of the two regimens, esomeprazole versus lansoprazole based triple therapy
Key secondary outcomes Comparison between adverse event rates in patients with esomeprazole versus lansoprazole based triple therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esomeprazole 20mg, AMPC 750mg, CAM 400mg, twice a day for 7days
Interventions/Control_2 Lansoprazole 10mg, AMPC 750mg, CAM 400mg, twice a day for 7days
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 past history of peptic ulcer, gastric MALT lymphoma, Idiopathic thrombocytopenic purpura, and early gastric cancer treated by endoscopic resection, related to H.pylori infection
Key exclusion criteria Past history of allergy for the drugs used in this study.
Past history of taking eradication therapy.
Past history of gastrectomy. Gastric cancer patients, pregnancy or lactation. Severe renal dysfunction, Blood disease, Infectious Mononucleosis Patients who are disqualified for the study by their physicians
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL http://www.med.osaka-u.ac.jp/pub/gh/
Email

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.wjgnet.com/1007-9327/abstract/v20/i15/4362.htm
Number of participants that the trial has enrolled
Results
Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H. pylori compared with lansoprazole.
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
2012 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 21 Day
Date trial data considered complete
2014 Year 04 Month 21 Day
Date analysis concluded
2014 Year 04 Month 21 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 12 Day
Last modified on
2014 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009035

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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