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

NCT00390390

Run by

Novartis

People needed

576

Starts

2006-06-01

Expected to finish

2007-01-01

Last updated by the study team

2010-05-25

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

• Sunbelt Research Group — Mobile, Alabama, United States
• Arkansas Primary Care Clinic — Little Rock, Alaska, United States
• Radiant Research — Chandler, Arizona, 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
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Palm Beach Research — West Palm Beach, Florida, United States
• Accelovance — Peoria, Illinois, United States
• IRSI — Rockland, Massachusetts, United States
• Prime Care Research — St Louis, Missouri, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Urgentmed — South Bound Brook, New Jersey, United States
• Wake research associates, Inc — Raleigh, North Carolina, United States
• Piedmont Medical Research — Winston-Salem, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States
• Wells Institute For Health Awareness — Kettering, Ohio, United States
• Toledo Center for Clinical Research — Sylvania, Ohio, United States
• Durham Physicans — Durham, Pennsylvania, United States
• 2222 State Street — Nashville, Tennessee, United States
• Wells Branch Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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