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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Disease (GERD); Heartburn; Indigestion	Drug: Secretol; Drug: Nexium	Phase 1; Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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).
Study Start Date :	May 2010
Estimated Primary Completion Date :	May 2015
Estimated Study Completion Date :	May 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Nexium; Comparing 40 mg.once daily in healing erosive esophagitis.	Drug: Nexium; Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.; Other Name: Esomeprazole
Active Comparator: Secretol; Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.	Drug: Secretol; Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.; Other Name: lansoprazole/omeprazole combination

Outcome Measures

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Primary Outcome Measures :

1. Primary objective is to evaluate the relationship between healing and study drug allotment. [ Time Frame: 3 weeks of treatment ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ronnie Fass, MD	520-792-1450 ext 5139	ronnie.fass@va.gov
Contact: Marcia R. Willis, BS,CCRC	520-792-1450 ext 2032	marcia.willis@va.gov

Locations

United States, Arizona
Southern Arizona Veterans Health Care System	Recruiting
Tucson, Arizona, United States, 85723
Principal Investigator: Ronnie Fass, MD

Sponsors and Collaborators

Effexus Pharmaceutical

Southern Arizona VA Health Care System

Investigators

Principal Investigator:	Ronnie Fass, MD	Southern Arizona VA Health Care System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Effexus Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01129713 History of Changes
Other Study ID Numbers:	NEXIUM versus SECRETOL
First Posted:	May 25, 2010
Last Update Posted:	August 5, 2014
Last Verified:	August 2014

Keywords provided by Effexus Pharmaceutical:

GERD; Acid Reflux; Heartburn; Regurgitation; Indigestion

Additional relevant MeSH terms:

Gastroesophageal Reflux; Heartburn; Dyspepsia; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive	Signs and Symptoms; Esomeprazole; Lansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action