臨床研究等提出・公開システム

Date of registration	Feb. 21, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220521

Scientific Title	A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double-Blind, Placebo Control, Parallel Assignment Study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Ages Eligible for Study: 20 Years and above Genders Eligible for Study: Both Inclusion Criteria: - Medical history of gastric and/or duodenal ulcer - A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age Exclusion Criteria: - Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification - History of esophageal, gastric or duodenal surgery - Having severe liver disease or chronic renal disease
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
Intervention(s)		investigational material(s) Generic name etc : esomeprazole INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety/Efficacy Primary Outcome Measures: - Presence or absence of gastric and/or duodenal ulcer throughout the treatment period (24 weeks) Secondary Outcome Measures: - Presence or absence of gastric and/or duodenal ulcers for up to 4 weeks and 12 weeks after initial administration, Severity of gastric mucosal lesion, Presence/absence and severity of NSAID-induced gastrointestinal symptoms, AEs, lab values, vital signs
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-080531
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 15, 2016	Detail	Changes
7	Dec. 15, 2016	Detail	Changes
6	Aug. 05, 2009	Detail	Changes
5	Aug. 05, 2009	Detail	Changes
4	Dec. 15, 2008	Detail	Changes
3	Dec. 15, 2008	Detail	Changes
2	Feb. 21, 2008	Detail	Changes
1	Feb. 21, 2008	Detail

List of change history