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Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago

Intervention: Esomeprazole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Naotsugu Oyama, Study Director, Affiliation: AstraZeneca Japan

Summary

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Clinical Details

Official title: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period

Secondary outcome:

Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Kyoto, Japan

Research Site, Nagano, Japan

Research Site, Oita, Japan

Research Site, Osaka, Japan

Research Site, Saitama, Japan

Research Site, Shizuoka, Japan

Research Site, Chiryu, Aichi, Japan

Research Site, Seto, Aichi, Japan

Research Site, Yotukaido, Chiba, Japan

Research Site, Mizumaki, Fukuoka, Japan

Research Site, Akashi, HYOGOi, Japan

Research Site, Sapporo, Hokkaido, Japan

Research Site, Itami, Hyogo, Japan

Research Site, Koto, Hyogo, Japan

Research Site, Nishinomiya, Hyogo, Japan

Research Site, Hitachi, Ibaragi, Japan

Research Site, Morioka, Iwate, Japan

Research Site, Sagamihara, Kanagawa, Japan

Research Site, Yokohama, Kanagawa, Japan

Research Site, Nagaokakyo, Kyoto, Japan

Research Site, Chiisagata, Nagano, Japan

Research Site, Matsumoto, Nagano, Japan

Research Site, Sasebo, Nagasaki, Japan

Research Site, Beppu, Oita, Japan

Research Site, Ihara, Okayama, Japan

Research Site, Hirakata, Osaka, Japan

Research Site, Sakai, Osaka, Japan

Research Site, Suita, Osaka, Japan

Research Site, Takatsuki, Osaka, Japan

Research Site, Kawagoe, Saitama, Japan

Research Site, Fukuroi, Shizuoka, Japan

Research Site, Hamamatsu, Shizuoka, Japan

Research Site, Izunokuni, Shizuoka, Japan

Research Site, Maikinohara, Shizuoka, Japan

Research Site, Yaizu, Shizuoka, Japan

Research Site, Shimotsuke, Tochigi, Japan

Research Site, Chiyoda, Tokyo, Japan

Research Site, Koto, Tokyo, Japan

Research Site, Musashimurayama, Tokyo, Japan

Additional Information

Starting date: August 2007
Last updated: May 10, 2010

Page last updated: August 23, 2015

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