Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Condition(s) targeted: Heartburn

Intervention: Lansoprazole (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.

Sunbelt Research Group, Mobile, Alabama 36608, United States

Arkansas Primary Care Clinic, Little Rock, Alaska 72204, United States

Radiant Research, Chandler, Arizona 85225, United States

Radiant Research - Scottsdale, Scottsdale, Arizona 85251, United States

Gaslamp Medical Center, San Diego, California 92101, United States

Edinger Medical Group, Fountain Valley, California 92709, United States

Expresscare Clinical Research, Colorado Springs, Colorado 80909, United States

Tampa Bay Medical Research, Inc., Clearwater, Florida 33761, United States

Central Florida Clinical Trials inc., Altamonte Springs, Florida 32714, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Palm Beach Research, West Palm Beach, Florida 33409, United States

Central Florida Clinical Trials inc., Altamonte Springs, Florida 32714, United States

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

Accelovance, Peoria, Illinois 61602, United States

IRSI, Rockland, Massachusetts 04841, United States

Prime Care Research, St. Louis, Missouri 63031, United States

Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States

Urgentmed, South Bound Brook, New Jersey 08880, United States

Wake research associates, Inc, Raleigh, North Carolina 27612, United States

Piedmont Medical Research, Winston Salem, North Carolina 27103, United States

Wells Institute For Health Awareness, Kettering, Ohio 45429, United States

Radiant Research, Cincinnati, Ohio 45236, United States

Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States

Durham Physicans, Durham, Pennsylvania 19047, United States

2222 State Street, Nashville, Tennessee 37203, United States

Wells Branch Medical Center, Austin, Texas 78728, United States

Medical Edge Healthcare Group, Dallas, Texas 75243, United States

Houston, Texas 77002, United States

Clinical Trials Network, Houston, Texas 77074, United States

Holston Medical Group, Weber City, Virginia 24290, United States

Health Research of Hampton Roads, Newport News, Virginia 23606, United States

NA

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