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

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 |
- 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
- 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

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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

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
Japan | |
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 | |
Research Site | |
Chiyoda, Tokyo, Japan | |
Research Site | |
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 | |
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Shizuoka, Japan |
Study Director: | Naotsugu Oyama | AstraZeneca Japan |
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 |
gastrointestinal GI NSAID Japan |
Japanese Gastric ulcer duodenal ulcer |
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 |