Status:
COMPLETED
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Lead Sponsor:
Novartis
Conditions:
Heartburn
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 efficac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00389948
Start Date
June 1 2006
End Date
January 1 2007
Last Update
April 16 2007
Active Locations (28)
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1
Clinical Research Consultants Inc.
Hoover, Alabama, United States, 35216
2
Huntsville, Alabama, United States, 35802
3
Radiant Research
Sierra Vista, Arizona, United States, 85635
4
California Bio Medical Research Institute
Los Angeles, California, United States, 90025