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Trial record 98 of 10804 for:    Placebo AND once

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542789
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Information provided by:

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

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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

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Placebo
once daily oral

Experimental: 2
Esomeprazole 20 mg
Drug: Esomeprazole
20mg once daily oral
Other Name: Nexium

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00542789

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Research Site
Chiryu, Aichi, Japan
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Seto, Aichi, Japan
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Yotukaido, Chiba, Japan
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Mizumaki, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Akashi, HYOGOi, Japan
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Itami, Hyogo, Japan
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Koto, Hyogo, Japan
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Nishinomiya, Hyogo, Japan
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Hitachi, Ibaragi, Japan
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Morioka, Iwate, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Nagaokakyo, Kyoto, Japan
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Chiisagata, Nagano, Japan
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Matsumoto, Nagano, Japan
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Sasebo, Nagasaki, Japan
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Beppu, Oita, Japan
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Ihara, Okayama, Japan
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Hirakata, Osaka, Japan
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Sakai, Osaka, Japan
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Suita, Osaka, Japan
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Takatsuki, Osaka, Japan
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Kawagoe, Saitama, Japan
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Fukuroi, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Maikinohara, Shizuoka, Japan
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Yaizu, Shizuoka, Japan
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Shimotsuke, Tochigi, Japan
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Chiyoda, Tokyo, Japan
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Koto, Tokyo, Japan
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Musashimurayama, Tokyo, Japan
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Kyoto, Japan
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Nagano, Japan
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Oita, Japan
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Osaka, Japan
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Saitama, Japan
Research Site
Shizuoka, Japan
Sponsors and Collaborators
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Study Director: Naotsugu Oyama AstraZeneca Japan

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00542789     History of Changes
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:
Gastric ulcer
duodenal ulcer

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Stomach Ulcer
Duodenal Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents