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

August 4, 2014 updated by: Effexus Pharmaceutical

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona Veterans Health Care System
        • Principal Investigator:
          • RONNIE FASS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • lansoprazole/omeprazole combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Effexus Pharmaceutical

Collaborators

Southern Arizona VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEXIUM versus SECRETOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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