Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Completed · Phase 3 · Has a placebo group

Conditions studied: Frequent Heartburn

In brief

Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

Key facts

Study ID

NCT00701259

Run by

Novartis

People needed

852

Starts

2007-01-01

Expected to finish

2007-08-01

Last updated by the study team

2010-01-15

Who can join

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

You may qualify if…

• Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
• 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 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

• Not applicable - enrollment complete — Parsippany, New Jersey, United States

Full record on ClinicalTrials.gov

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