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

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ClinicalTrials.gov Identifier: NCT01129713
Recruitment Status : Unknown
Verified August 2014 by Effexus Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : May 25, 2010
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Effexus Pharmaceutical

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129713


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

Responsible Party: Effexus Pharmaceutical
ClinicalTrials.gov Identifier: NCT01129713     History of Changes
Other Study ID Numbers: NEXIUM versus SECRETOL
First Posted: May 25, 2010    Key Record Dates
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