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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00401752 |
The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy.
Condition | Intervention | Phase |
---|---|---|
Gastric Ulcer |
Drug: Esomeprazole Drug: Ranitidine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg qd Versus Ranitidine 150 mg Bid in Patients With an NSAID-Associated Gastric Ulcer When Daily NSAID is Continued |
Estimated Enrollment: | 320 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Research Site | |
Shanghai, China | |
Research Site | |
Beijing, China | |
China, Fujian | |
Research Site | |
Fuzhou, Fujian, China | |
China, Guangdong | |
Research Site | |
Guangzhou, Guangdong, China | |
China, Hubei | |
Research Site | |
Wuhan, Hubei, China | |
China, Jiangsu | |
Research Site | |
Suzhou, Jiangsu, China | |
China, Liaoning | |
Research Site | |
Shenyang, Liaoning, China | |
China, Shanxi | |
Research Site | |
Xi'an, Shanxi, China | |
Hong Kong | |
Research Site | |
Hong Kong, Hong Kong |
Study Director: | Tore Lind, MD | AstraZeneca |
Study ID Numbers: | D9617L00001 |
Study First Received: | November 17, 2006 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00401752 History of Changes |
Health Authority: | China: State Food and Drug Administration |
NSAID-associated gastric ulcer |
Stomach Ulcer Anti-Inflammatory Agents Neurotransmitter Agents Bismuth tripotassium dicitrate Gastrointestinal Diseases Ulcer Citric Acid Omeprazole Histamine H2 Antagonists Histamine Bismuth Ranitidine |
Digestive System Diseases Stomach Diseases Histamine Antagonists Ranitidine bismuth citrate Analgesics, Non-Narcotic Histamine phosphate Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Peptic Ulcer |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Omeprazole Pathologic Processes Stomach Diseases Ranitidine bismuth citrate Sensory System Agents Therapeutic Uses Anti-Ulcer Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Peptic Ulcer Stomach Ulcer Ulcer Gastrointestinal Agents Histamine Agents Enzyme Inhibitors Pharmacologic Actions Histamine H2 Antagonists Ranitidine Digestive System Diseases Histamine Antagonists Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents |