Heartburn
Conditions
Keywords
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
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.
Interventions
DRUGLansoprazole
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Experiencing heartburn at least 2 days per week over the past month. 2. Having heartburn that responds to heartburn medication. 3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
Exclusion criteria
1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed