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
30
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
30 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
CompletedMay 25, 2010
April 1, 2007
October 18, 2006
May 24, 2010
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 (30)
Sunbelt Research Group
Mobile, Alabama, 36608, United States
Arkansas Primary Care Clinic
Little Rock, Alaska, 72204, United States
Radiant Research
Chandler, Arizona, 85225, United States
Radiant Research - Scottsdale
Scottsdale, Arizona, 85251, United States
Edinger Medical Group
Fountain Valley, California, 92709, United States
Gaslamp Medical Center
San Diego, California, 92101, United States
Expresscare Clinical Research
Colorado Springs, Colorado, 80909, United States
Central Florida Clinical Trials inc.
Altamonte Springs, Florida, 32714, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
Health Awareness Inc.
Jupiter, Florida, 33458, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Palm Beach Research
West Palm Beach, Florida, 33409, United States
Accelovance
Peoria, Illinois, 61602, United States
IRSI
Rockland, Massachusetts, 04841, United States
Prime Care Research
St Louis, Missouri, 63031, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Urgentmed
South Bound Brook, New Jersey, 08880, United States
Wake research associates, Inc
Raleigh, North Carolina, 27612, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
Durham Physicans
Durham, Pennsylvania, 19047, United States
2222 State Street
Nashville, Tennessee, 37203, United States
Wells Branch Medical Center
Austin, Texas, 78728, United States
Medical Edge Healthcare Group
Dallas, Texas, 75243, United States
Unknown Facility
Houston, Texas, 77002, United States
Clinical Trials Network
Houston, Texas, 77074, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
Holston Medical Group
Weber City, Virginia, 24290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
May 25, 2010
Record last verified: 2007-04