Back to resultsEfficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Primary Purpose
Frequent Heartburn
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lansoprazole
Lansoprazole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Frequent Heartburn focused on measuring Frequent heartburn, proton pump inhibitor, lansoprazole, Treatment of, over 14 days
Eligibility 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"
Sites / Locations
- Not applicable - enrollment complete
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
15 mg lansoprazole
30 mg lansoprazole
placebo
Outcomes
Primary Outcome Measures
Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00701259
Brief Title
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frequent Heartburn
Keywords
Frequent heartburn, proton pump inhibitor, lansoprazole, Treatment of, over 14 days
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
852 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
15 mg lansoprazole
Arm Title
2
Arm Type
Experimental
Arm Description
30 mg lansoprazole
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid - United States
Intervention Description
Lansoprazole 15 mg once per day for 14 days
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Lansoprazole 30 mg once per day for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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"
Facility Information:
Facility Name
Not applicable - enrollment complete
City
Parsippany
State/Province
New Jersey
ZIP/Postal Code
07054
Country
United States
12. IPD Sharing Statement
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Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
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