Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Digestive & Liver Disease Specialists
• Collaborator: AstraZeneca
• Treatments: Antacids

Criteria

Inclusion Criteria:

• 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

• Females of childbearing potential must use an acceptable method of birth control for the duration of the study.

Exclusion Criteria:

• 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