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 |
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Recruitment Status :
Completed
First Posted : October 12, 2007
Results First Posted : May 28, 2010
Last Update Posted : May 28, 2010
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Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
- Study Details
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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 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
Drug Information available for:
Esomeprazole
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
Placebo
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Drug: Placebo
once daily oral |
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Experimental: 2
Esomeprazole 20 mg
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Drug: Esomeprazole
20mg once daily oral
Other Name: Nexium |
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
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 |
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
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
| 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
| Study Director: | Naotsugu Oyama | AstraZeneca Japan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov 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:
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gastrointestinal GI NSAID Japan |
Japanese Gastric ulcer duodenal ulcer |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis, Rheumatoid Ulcer Stomach Ulcer Duodenal Ulcer Arthritis 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 Esomeprazole Anti-Inflammatory Agents, Non-Steroidal Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |