Frequent Heartburn
Conditions
Keywords
Frequent heartburn, proton pump inhibitor, lansoprazole, Treatment of, over 14 days
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.
Interventions
DRUGLansoprazole
Lansoprazole 15 mg once per day for 14 days
DRUGplacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed