Status:
COMPLETED
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Lead Sponsor:
Novartis
Conditions:
Frequent Heartburn
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety a...
Eligibility Criteria
Inclusion
- Experiencing heartburn at least 2 days per week during the nighttime period 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/exclusion criteria may apply"
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
852 Patients enrolled
Trial Details
Trial ID
NCT00701259
Start Date
January 1 2007
End Date
August 1 2007
Last Update
January 15 2010
Active Locations (1)
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1
Not applicable - enrollment complete
Parsippany, New Jersey, United States, 07054