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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016410
Receipt No. 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

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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
Email 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
Email haradan@kyumed.jp

Sponsor
Institute National Hospital Organization
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019010

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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