Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Effexus Pharmaceutical
• Collaborator: Southern Arizona VA Health Care System
• Treatments: Esomeprazole; Lansoprazole; Omeprazole

Criteria

Inclusion Criteria:

• Male or Female

• Ages 18-75

• EE Los Angeles grades C or D

• Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.

• Able to read, understand, and complete study questionnaires and record

• Able to understand the study procedures and sign informed consent

• Able to comply with all study requirements

Exclusion Criteria:

• Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy

• Subjects with previous upper gastrointestinal surgery

• Subjects with clinically significant underlying comorbidity

• Helicobacter pylori positive

• Clinically significant GI bleed within the last 3 months

• Esophagitis not related to acid reflux

• Bleeding disorder

• Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy

• Women pregnant or lactating

• History of allergic reaction to any Proton Pump Inhibitor (PPI)

• Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS > 3 times/week

• Any medication dependant on gastric acid for optimal absorption