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Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

NCT ID: NCT00595517

Last Updated: 2012-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Detailed Description

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Conditions

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Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago

Keywords

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gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Esomeprazole 20 mg

Esomeprazole 20 mg once daily

Group Type EXPERIMENTAL

Esomeprazole 20 mg

Intervention Type DRUG

Esomeprazole 20 mg once daily

Interventions

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Esomeprazole 20 mg

Esomeprazole 20 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naotsugu Oyama

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Ōita, , Japan

Site Status

Research Site

Saitama, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.

Reference Type DERIVED
PMID: 23530709 (View on PubMed)

Other Identifiers

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D961HC00005

Identifier Type: -

Identifier Source: org_study_id