Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
Single Dose Nexium 40MG QAM vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2005
Typical duration for phase_4
1 active site
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
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 25, 2009
February 1, 2009
February 22, 2006
February 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of subjects who are successfully stepped-down to single-dose PPI therapy, defined as having no recurrence of heartburn or acid regurgitation 3 months after PPI step-down.
Secondary Outcomes (1)
Changes in GERD symptom scores, health related quality of life, ancillary medication expenditures, and predictors of successful step-down.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Digestive & Liver Disease Specialistslead
- AstraZenecacollaborator
Study Sites (1)
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Johnson, MD
Digestive & Liver Disease Specialists
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
October 1, 2005
Study Completion
December 1, 2007
Last Updated
February 25, 2009
Record last verified: 2009-02