Heartburn Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Southern Arizona Veterans Health Care System | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Effexus Pharmaceutical | Southern Arizona VA Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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