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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00389948 |
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
Condition | Intervention | Phase |
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Heartburn |
Drug: Lanzoprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn |
Estimated Enrollment: | 576 |
Study Start Date: | June 2006 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion or exclusion criteria may apply
Study ID Numbers: | PRSW-GN-301 |
Study First Received: | October 18, 2006 |
Last Updated: | April 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00389948 |
Health Authority: | United States: Food and Drug Administration |
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole |
Signs and Symptoms Pyrosis Signs and Symptoms, Digestive Heartburn Lansoprazole |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |