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

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

Detailed Description
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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.

Official Title
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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).

Conditions
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Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion

Intervention / Treatment
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* Drug: Secretol
* Drug: Nexium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nexium<br>Comparing 40 mg.once daily in healing erosive esophagitis. | Drug: Nexium<br>* Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.<br>* Other names: Esomeprazole;|
| Active Comparator: Secretol<br>Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis. | Drug: Secretol<br>* Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.<br>* Other names: lansoprazole/omeprazole combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to evaluate the relationship between healing and study drug allotment. | The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD. | 3 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion