Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Phase 3

Completed

• Conditions: Heartburn

• Registration Number: NCT00390390
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Completion: 2007-01
• Status Verified: 2007-04
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (28)

Sunbelt Research Group; 🇺🇸 Mobile, Alabama, United States

Arkansas Primary Care Clinic; 🇺🇸 Little Rock, Alaska, United States

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States

Radiant Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Edinger Medical Group; 🇺🇸 Fountain Valley, California, United States

Gaslamp Medical Center; 🇺🇸 San Diego, California, United States

Expresscare Clinical Research; 🇺🇸 Colorado Springs, Colorado, United States

Central Florida Clinical Trials inc.; 🇺🇸 Altamonte Springs, Florida, United States

Tampa Bay Medical Research, Inc.; 🇺🇸 Clearwater, Florida, United States

Health Awareness Inc.; 🇺🇸 Jupiter, Florida, United States

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