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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00206284 |
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.
Condition | Intervention | Phase |
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GERD Without Erosive Esophagitis |
Drug: AZD0865 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A 4-Week, Randomised, Double-Blind, Multicentre, Dose-Finding Phase IIb Study With AZD0865 25, 50, 75 Mg and Esomeprazole 20 Mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects. |
Estimated Enrollment: | 1400 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with current or historical evidence of the following conditions are excluded from the study:
Subjects with i) history of significant or ii) current significant or unstable:
Study ID Numbers: | D9770C00011 |
Study First Received: | September 15, 2005 |
Last Updated: | September 26, 2005 |
ClinicalTrials.gov Identifier: | NCT00206284 |
Health Authority: | United States: Food and Drug Administration |
GERD without erosive esophagitis |
Deglutition Disorders Esophageal Motility Disorders Signs and Symptoms Esophagitis Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Omeprazole Esophageal Diseases Gastroenteritis Gastroesophageal Reflux |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |