Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
Completed · Phase 4
Conditions studied: GERD
In brief
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.
Key facts
- Study ID
- NCT00295685
- Run by
- Digestive & Liver Disease Specialists
- People needed
- 50
- Starts
- 2005-10-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2009-02-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Digestive & Liver Disease Specialists — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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