Phase 2
Completed N=120
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Heartburn
Source: ClinicalTrials.gov NCT01037452 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal — 0; 2; 1; 0 participants
Summary
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal |
0; 2; 1; 0 | — |
| SECONDARY Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals |
69.3; 61.2; 59.1; 56.9 | — |
| SECONDARY Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn |
8.2; 7.0; 4.7; 4.0 | — |
| SECONDARY Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. |
0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Experiencing heartburn in the past month if untreated
- 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 (GERD) 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"
Data sourced from ClinicalTrials.gov (NCT01037452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.