Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Novartis852 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

852

Conditions

Frequent Heartburn

Interventions

LansoprazoleDRUG

Lansoprazole 15 mg once per day for 14 days

LansoprazoleDRUG

Lansoprazole 30 mg once per day for 14 days

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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"

Locations (1)

Not applicable - enrollment complete

Parsippany, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.

Time frame: 14 days

Secondary Outcomes

Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety.

Time frame: 14 days

Data from ClinicalTrials.gov

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