Status:
COMPLETED
Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
Lead Sponsor:
Digestive & Liver Disease Specialists
Collaborating Sponsors:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if people taking lansoprazole two times a day to control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium just once a day.
Detailed Description
approximately 20% of patients taking first generation proton pump inhibitors (PPIs) are taking more than the standard approved dose. This dosing is required to attain adequate control of the gastric a...
Eligibility Criteria
Inclusion
- Previous diagnosis of severe GERD.
- Male or female 18-80 years of age
- Ability to read, understand and provide informed consent
- GERD is Adequately controlled on BID lansoprazole as evidenced by GERD-HRQL score of \</= 11
- Females of childbearing potential must use an acceptable method of birth control for the duration of the study.
Exclusion
- Known contraindications to Nexium
- Current or historical evidence of \>3 cm histologically confirmed Barrett's metaplasia without current dysplasia, esophageal stricture or extraesophageal GERD symptoms.
- Previous Esophageal gastric surgery
- Pregnant or nursing Females
- Clinically significant abnormal laboratory values
- Medical condition that may be adversely impacted by participation in this study
- History of or current drug or alcohol abuse
- Known malignancy
- Need for concurrent therapy with any acid suppressive therapy other than the study drug, antacids, alginates, NSAIDS, \>165 mg ASA, prostaglandin analogs, prokinetic drug, antineoplastic agents, Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Telithromycin, HIV protease inhibitors, Rifampin, Phenobarbital, or Digoxin
- Use of investigational drug or experimental device within 30 days prior to screening
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00295685
Start Date
October 1 2005
End Date
December 1 2007
Last Update
February 25 2009
Active Locations (1)
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1
Digestive & Liver Disease Specialists
Norfolk, Virginia, United States, 23502