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Comparison of Nexium VS. Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE. - NCT01129713-85723(Clinical Trial 651081)



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City:  Tucson
State:  
AZ
Zip Code: 85723
Conditions: Gastroesophageal Reflux Disease (GERD) - Heartburn - Indigestion
Purpose: To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 60 mg versus Nexium 40 mg daily.
Study summary: We hypothesize that Secretol 60 mg 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 60 mg daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.
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 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
Study is available at: Southern Arizona Veterans Health Care System
Tucson, AZ 85723
United States

Primary Contact:
Ronnie Fass, MD
Email: ronnie.fass@va.gov
Phone: 520-792-1450
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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