UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016410 |
|---|---|
| Receipt number | R000019010 |
| Scientific Title | Randomized comparative study for efficacy of esomeprazole and lansoprazole in the prevention of recurrent gastroduodenal ulcer in patients continuously treated with non-steroidal anti-inflammatory drugs |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2017/02/02 13:00:36 |
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Basic information
Public title
Randomized comparative study for efficacy of esomeprazole and lansoprazole in the prevention of recurrent gastroduodenal ulcer in patients continuously treated with non-steroidal anti-inflammatory drugs
Acronym
EPZvsLPZ study
Scientific Title
Randomized comparative study for efficacy of esomeprazole and lansoprazole in the prevention of recurrent gastroduodenal ulcer in patients continuously treated with non-steroidal anti-inflammatory drugs
Scientific Title:Acronym
EPZvsLPZ study
Region
| Japan |
Condition
Condition
Gastroduodenal ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of esomeprazole 20mg and lansoprazole 15mg in the prevention of recurrent gastroduodenal ulcer in patients continuously treated with non-steroidal anti-inflammatory drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-recurrent rate of gastroduodenal ulcer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Esomeprazole 20mg once a day for 12 months
Interventions/Control_2
Lansoprazole 15mg once a day for 12 months
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 with endoscopic diagnosed as gastroduodenal ulcer scar, and continuously treated with non-steroidal anti-inflammatory drugs
2) patients accepted to registration for this study
3) patients with informed consent
Key exclusion criteria
1) Patients with severe heart disease, acute cerebrovascular disease, hematological disease, severe liver disease, severe renal disease, or malignancy.
2) Pregnant women
3) Patients treated with Reyataz or Edulant
4) Patients with allergy for proton pump inhibitor
5) Patients with active gastroduodenal ulcers on the first time of this study
6) Patients with operative history of esophagus or stomach
7) Patients treated with steroids
8) Patients with alcoholism or drug dependence
9) Patients judged as unsuitable by investigator
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Harada |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
haradan@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiko Harada |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
haradan@kyumed.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019010
| Research Plan | |
|---|---|
| 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 |
