Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Completed · Phase 3

Conditions studied: Heartburn

In brief

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.

Key facts

Study ID

NCT00389948

Run by

Novartis

People needed

576

Starts

2006-06-01

Expected to finish

2007-01-01

Last updated by the study team

2007-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Experiencing heartburn at least 2 days per week over the past month.
• Having heartburn that responds to heartburn medication.
• Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

You may not qualify if…

• Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
• 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

Where it is running

• Clinical Research Consultants Inc. — Hoover, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Radiant Research — Sierra Vista, Arizona, United States
• California Bio Medical Research Institute — Los Angeles, California, United States
• Allergy Medical Group of North Area — Roseville, California, United States
• Eastern Research — Hialeah, Florida, United States
• Health Awareness Inc. — Jupiter, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Radiant Research — Atlanta, Georgia, United States
• Radiant Research — Atlanta, Georgia, United States
• Study site — Evansville, Indiana, United States
• Clinical Associates — Reisterstown, Maryland, United States
• Medex Healthcare Research, Inc. — St Louis, Missouri, United States
• Meridian Clinical Research LLC — Omaha, Nebraska, United States
• William W. Anderson M.D. P.C. — Rio Rancho, New Mexico, United States
• IRSI — Port Chester, New York, United States
• Crescent Medical Research — Salisbury, North Carolina, United States
• Micheal Alexander, DO — Columbus, Ohio, United States
• New Hope Research of Oregon — Portland, Oregon, United States
• Preferred Primary Care Physicians — Carnegie, Pennsylvania, United States
• Advanced Therapeutics, Inc — Johnson City, Tennessee, United States
• Nashville Medical Research — Nashville, Tennessee, United States
• Medical Edge Healthcare Group, P.A. — Dallas, Texas, United States
• Benchmark Research — Fort Worth, Texas, United States
• Benchmark Research — San Angelo, Texas, United States

Full record on ClinicalTrials.gov

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