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

Completed · Phase 2 · Has a placebo group

Conditions studied: Heartburn

In brief

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.

Key facts

Study ID

NCT01037452

Run by

Novartis

People needed

120

Starts

2009-12-01

Last updated by the study team

2011-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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"

Where it is running

• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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