Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Frequent Heartburn
Intervention: Lansoprazole (Drug); Lansoprazole (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis
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 and efficacy of lansoprazole 15 mg or 30 mg administered once a day in
preventing frequent nighttime heartburn.
Clinical Details
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
Secondary outcome: Proportion of 24 hour days with no heartburn during 14 days of treatment.
Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose.
The evaluation of lansoprazole safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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"
Locations and Contacts
Not applicable - enrollment complete, Parsippany, New Jersey 07054, United States
Additional Information
Starting date: January 2007
Ending date: August 2007
Last updated: June 18, 2008
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