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Tracking Information | |||||
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First Received Date † | November 17, 2006 | ||||
Last Updated Date | March 11, 2009 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
Assess the efficacy of esomeprazole 20 mg qd through 4 weeks of treatment in these patients | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00401752 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-Induced Gastric Ulcer | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Gastric Ulcer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 320 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | China, Hong Kong | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00401752 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | AstraZeneca | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | AstraZeneca | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |