Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Novartis576 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

576

Conditions

Heartburn

Interventions

LanzoprazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Experiencing heartburn at least 2 days per week over the past month. 2. Having heartburn that responds to heartburn medication. 3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. Exclusion Criteria: 1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). 2. 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 or exclusion criteria may apply

Locations (28)

Outcomes

Primary Outcomes

To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.

Secondary Outcomes

To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo

To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo

Evaluation of lansoprazole safety.

Data from ClinicalTrials.gov

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