Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antacids; Anti-Ulcer Agents; Calcium; Calcium Carbonate; Calcium, Dietary; Dexlansoprazole; Lansoprazole; Magnesium Hydroxide

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"