View Clinical Trial (Medical Research Study)
Comparison of Nexium VS. Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
| City: |
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Tucson |
| State: |
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Arizona |
| Zip Code: |
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85723 |
| Conditions: |
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Gastroesophageal Reflux Disease (GERD) - Heartburn - Indigestion |
| Purpose: |
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To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with
Secretol 60 mg versus Nexium 40 mg daily.
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| Study Summary: |
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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.
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| 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 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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| NCT ID: |
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NCT01129713 |
| Primary Contact: |
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Principal Investigator
Ronnie Fass, MD
Southern Arizona VA Health Care System
Ronnie Fass, MD
Phone: 520-792-1450 ext. 5139
Email: ronnie.fass@va.gov
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| Backup Contact: |
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Email: marcia.willis@va.gov
Marcia R. Willis, BS,CCRC
Phone: 520-792-1450 ext. 2032
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| Location Contact: |
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Tucson, Arizona 85723
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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