Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
1 other identifier
interventional
576
1 country
28
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 efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 18, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedApril 16, 2007
April 1, 2007
October 18, 2006
April 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
Secondary Outcomes (3)
To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Evaluation of lansoprazole safety.
Interventions
Eligibility Criteria
You may qualify if:
- Experiencing heartburn at least 2 days per week over the past month.
- Having heartburn that responds to heartburn medication.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (28)
Clinical Research Consultants Inc.
Hoover, Alabama, 35216, United States
Unknown Facility
Huntsville, Alabama, 35802, United States
Radiant Research
Sierra Vista, Arizona, 85635, United States
California Bio Medical Research Institute
Los Angeles, California, 90025, United States
Allergy Medical Group of North Area
Roseville, California, 95678, United States
Eastern Research
Hialeah, Florida, 33013, United States
Health Awareness Inc.
Jupiter, Florida, 33458, United States
Miami Research Associates
Miami, Florida, 33173, United States
Radiant Research
Atlanta, Georgia, 30252, United States
Radiant Research
Atlanta, Georgia, 30308, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Clinical Associates
Reisterstown, Maryland, 21136, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
William W. Anderson M.D. P.C.
Rio Rancho, New Mexico, 87124, United States
IRSI
Port Chester, New York, 10573, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Micheal Alexander, DO
Columbus, Ohio, 43204, United States
New Hope Research of Oregon
Portland, Oregon, 97219, United States
Preferred Primary Care Physicians
Carnegie, Pennsylvania, 15106, United States
Advanced Therapeutics, Inc
Johnson City, Tennessee, 37601, United States
Nashville Medical Research
Nashville, Tennessee, 37205, United States
Medical Edge Healthcare Group, P.A.
Dallas, Texas, 75243, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Commonwealth Clinical Research Specialist
Richmond, Virginia, 23226, United States
National Clinical Research Inc.
Richmond, Virginia, 23294, United States
Radiant Research
Lakewood, Washington, 98499, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2006
First Posted
October 19, 2006
Study Start
June 1, 2006
Study Completion
January 1, 2007
Last Updated
April 16, 2007
Record last verified: 2007-04