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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion

In brief

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

Key facts

Study ID

NCT01129713

Run by

Effexus Pharmaceutical

People needed

40

Starts

2010-05-01

Expected to finish

2015-05-01

Last updated by the study team

2014-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern Arizona Veterans Health Care System — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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