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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 11, 2007
Last updated: May 10, 2010
Last verified: May 2010
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 Intervention Phase
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago Drug: Esomeprazole Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

Enrollment: 343
Study Start Date: August 2007
Study Completion Date: February 2009
Arms Assigned Interventions
Placebo Comparator: 1
Drug: Placebo
once daily oral
Experimental: 2
Esomeprazole 20 mg
Drug: Esomeprazole
20mg once daily oral
Other Name: Nexium


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00542789

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
Study Director: Naotsugu Oyama AstraZeneca Japan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00542789     History of Changes
Other Study ID Numbers: D961HC00001
Study First Received: October 11, 2007
Results First Received: February 16, 2010
Last Updated: May 10, 2010

Keywords provided by AstraZeneca:
Gastric ulcer
duodenal ulcer

Additional relevant MeSH terms:
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 processed this record on September 21, 2017