Clinical Trial: Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: October 18, 2006
Date Started: June 2006
Date Completion:
Last Updated: April 13, 2007
Last Verified: April 2007
