Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
- To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
- To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
- Evaluation of lansoprazole safety.
|Study Start Date:||June 2006|
|Study Completion Date:||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389948
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