Heartburn
Conditions
Brief summary
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent * A history of heartburn for at least 6 months * A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy * A positive esophageal acid perfusion test * At least 3 days of 'moderate' severity heartburn over the previous 7 days * No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization
Exclusion criteria
* A history of gastric or esophageal surgery * H. pylori positive * A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization * Currently taking higher than the standard approved proton pump inhibitor doses * Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of None. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative daily sustained resolution rate through 4 weeks of treatment | — |
| Time to first day of the first 7-day period of sustained resolution of heartburn | — |
| Time to the first day of the first 7-day period of relief of heartburn | — |
| Relief of heartburn during the 4th week of treatment | — |
| Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment | — |
| Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination. | — |
| Percentage of subject-reported heartburn-free days through 4 weeks of treatment | — |
Countries
Puerto Rico, United States
Outcome results
None listed