Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
- Conditions
- Heartburn
- Registration Number
- NCT00389948
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
- Experiencing heartburn at least 2 days per week over the past month.
- Having heartburn that responds to heartburn medication.
- Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
- Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
- Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
Other protocol-defined inclusion or exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (22)
Clinical Research Consultants Inc.
🇺🇸Hoover, Alabama, United States
Radiant Research
🇺🇸Lakewood, Washington, United States
California Bio Medical Research Institute
🇺🇸Los Angeles, California, United States
Allergy Medical Group of North Area
🇺🇸Roseville, California, United States
Eastern Research
🇺🇸Hialeah, Florida, United States
Health Awareness Inc.
🇺🇸Jupiter, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Clinical Associates
🇺🇸Reisterstown, Maryland, United States
Medex Healthcare Research, Inc.
🇺🇸St. Louis, Missouri, United States
Meridian Clinical Research LLC
🇺🇸Omaha, Nebraska, United States
Scroll for more (12 remaining)Clinical Research Consultants Inc.🇺🇸Hoover, Alabama, United States