Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Phase 3

Completed

• Conditions: Heartburn

• Registration Number: NCT00389948
• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2007-04-13
• Last Update Posted: 2007-04-16

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.

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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

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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 (22)

William W. Anderson M.D. P.C.; 🇺🇸 Rio Rancho, New Mexico, United States

Benchmark Research; 🇺🇸 San Angelo, Texas, United States

Micheal Alexander, DO; 🇺🇸 Columbus, Ohio, United States

Allergy Medical Group of North Area; 🇺🇸 Roseville, California, United States

IRSI; 🇺🇸 Port Chester, New York, United States

Advanced Therapeutics, Inc; 🇺🇸 Johnson City, Tennessee, United States

Eastern Research; 🇺🇸 Hialeah, Florida, United States

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

Medex Healthcare Research, Inc.; 🇺🇸 St. Louis, Missouri, United States

Clinical Research Consultants Inc.; 🇺🇸 Hoover, Alabama, United States

Clinical Associates; 🇺🇸 Reisterstown, Maryland, United States

Medical Edge Healthcare Group, P.A.; 🇺🇸 Dallas, Texas, United States

Crescent Medical Research; 🇺🇸 Salisbury, North Carolina, United States

Preferred Primary Care Physicians; 🇺🇸 Carnegie, Pennsylvania, United States

California Bio Medical Research Institute; 🇺🇸 Los Angeles, California, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Meridian Clinical Research LLC; 🇺🇸 Omaha, Nebraska, United States

New Hope Research of Oregon; 🇺🇸 Portland, Oregon, United States

Nashville Medical Research; 🇺🇸 Nashville, Tennessee, United States

Commonwealth Clinical Research Specialist; 🇺🇸 Richmond, Virginia, United States

National Clinical Research Inc.; 🇺🇸 Richmond, Virginia, United States

Radiant Research; 🇺🇸 Lakewood, Washington, United States