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

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ClinicalTrials.gov Identifier: NCT00542789
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago Drug: Esomeprazole Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : August 2007
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Placebo
 Drug: Placebo
once daily oral
Experimental: 2
Esomeprazole 20 mg
 Drug: Esomeprazole
20mg once daily oral
Other Name: Nexium


Outcome Measures
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Primary Outcome Measures :
  1. Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period [ Time Frame: each visit up to 24 weeks ]
    The absence of gastric and/or duodenal ulcer throughout the treatment period


Secondary Outcome Measures :
  1. Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks ]
    The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment

  2. Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [ Time Frame: up to 12 weeks ]
    The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542789


Locations
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Japan
Research Site
Chiryu, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Yotukaido, Chiba, Japan
Research Site
Mizumaki, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, HYOGOi, 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
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Shizuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Naotsugu Oyama AstraZeneca Japan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00542789    
Other Study ID Numbers: D961HC00001
First Posted: October 12, 2007    Key Record Dates
Results First Posted: May 28, 2010
Last Update Posted: May 28, 2010
Last Verified: May 2010
Keywords provided by AstraZeneca:
gastrointestinal
GI
NSAID
Japan
 Japanese
Gastric ulcer
duodenal ulcer
Additional relevant MeSH terms:
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Stomach Ulcer
Duodenal Ulcer
Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action