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



Status:Completed
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:May 2010
End Date:May 2015
Contact:Ronnie Fass, MD
Email:ronnie.fass@va.gov
Phone:520-792-1450

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Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).

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

We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg
daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux
disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily
will have a faster effect on the aforementioned clinical parameters but a similar safety
profile.

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
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