Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
- Registration Number
- NCT00701259
- Lead Sponsor
- Novartis
- Brief Summary
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 852
Inclusion Criteria
- Experiencing heartburn at least 2 days per week during the nighttime period 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.
Exclusion Criteria
- 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/exclusion criteria may apply"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lansoprazole 15 mg lansoprazole 2 Lansoprazole 30 mg lansoprazole 3 placebo placebo
- Primary Outcome Measures
Name Time Method Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. 14 days
- Secondary Outcome Measures
Name Time Method Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety. 14 days
Trial Locations
- Locations (1)
Not applicable - enrollment complete
🇺🇸Parsippany, New Jersey, United States