Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Condition(s) targeted: Heartburn

Intervention: Lanzoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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.

Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Clinical Research Consultants Inc., Hoover, Alabama 35216, United States

Huntsville, Alabama 35802, United States

Radiant Research, Sierra Vista, Arizona 85635, United States

California Bio Medical Research Institute, Los Angeles, California 90025, United States

Allergy Medical Group of North Area, Roseville, California 95678, United States

Eastern Research, Hialeah, Florida 33013, United States

Miami Research Associates, Miami, Florida 33173, United States

Health Awareness Inc., Jupiter, Florida 33458, United States

Radiant Research, Atlanta, Georgia 30252, United States

Radiant Research, Atlanta, Georgia 30308, United States

Evansville, Indiana 47714, United States

Clinical Associates, Reisterstown, Maryland 21136, United States

Medex Healthcare Research, Inc., St. Louis, Missouri 63117, United States

Meridian Clinical Research LLC, Omaha, Nebraska 68134, United States

William W. Anderson M.D. P.C., Rio Rancho, New Mexico 87124, United States

IRSI, Port Chester, New York 10573, United States

Crescent Medical Research, Salisbury, North Carolina 28144, United States

Micheal Alexander, DO, Columbus, Ohio 43204, United States

New Hope Research of Oregon, Portland, Oregon 97219, United States

Preferred Primary Care Physicians, Carnegie, Pennsylvania 15106, United States

Advanced Therapeutics, Inc, Johnson City, Tennessee 37601, United States

Nashville Medical Research, Nashville, Tennessee 37205, United States

Medical Edge Healthcare Group, P.A., Dallas, Texas 75243, United States

Benchmark Research, San Angelo, Texas 76904, United States

Benchmark Research, Fort Worth, Texas 76135, United States

Commonwealth Clinical Research Specialist, Richmond, Virginia 23226, United States

National Clinical Research Inc., Richmond, Virginia 23294, United States

Radiant Research, Lakewood, Washington 98499, United States

NA

Starting date: June 2006
Ending date: January 2007
Last updated: April 13, 2007