UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Naohiko Harada
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterology
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	Naohiko Harada
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019010