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 |
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.
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.
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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