UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007733 |
|---|---|
| Receipt number | 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 18:18:14 |
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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
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/
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009035
