Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
- Conditions
- Heartburn
- Registration Number
- NCT00390390
- 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 (28)
Palm Beach Research
🇺🇸West Palm Beach, Florida, United States
Medical Edge Healthcare Group
🇺🇸Dallas, Texas, United States
Gaslamp Medical Center
🇺🇸San Diego, California, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
2222 State Street
🇺🇸Nashville, Tennessee, United States
Radiant Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Sunbelt Research Group
🇺🇸Mobile, Alabama, United States
Arkansas Primary Care Clinic
🇺🇸Little Rock, Alaska, United States
Edinger Medical Group
🇺🇸Fountain Valley, California, United States
Expresscare Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
Central Florida Clinical Trials inc.
🇺🇸Altamonte Springs, Florida, United States
Health Awareness Inc.
🇺🇸Jupiter, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Accelovance
🇺🇸Peoria, Illinois, United States
Prime Care Research
🇺🇸St. Louis, Missouri, United States
Urgentmed
🇺🇸South Bound Brook, New Jersey, United States
IRSI
🇺🇸Rockland, Massachusetts, United States
Wake research associates, Inc
🇺🇸Raleigh, North Carolina, United States
Wells Institute For Health Awareness
🇺🇸Kettering, Ohio, United States
Durham Physicans
🇺🇸Durham, Pennsylvania, United States
Piedmont Medical Research
🇺🇸Winston Salem, North Carolina, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Wells Branch Medical Center
🇺🇸Austin, Texas, United States
Holston Medical Group
🇺🇸Weber City, Virginia, United States
Health Research of Hampton Roads
🇺🇸Newport News, Virginia, United States
Clinical Trials Network
🇺🇸Houston, Texas, United States
Radiant Research
🇺🇸Cincinnati, Ohio, United States