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

Primary Purpose

Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Secretol
Nexium
Sponsored by
Effexus Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Arizona Veterans Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nexium

Secretol

Arm Description

Comparing 40 mg.once daily in healing erosive esophagitis.

Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.

Outcomes

Primary Outcome Measures

Primary objective is to evaluate the relationship between healing and study drug allotment.
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2010
Last Updated
August 4, 2014
Sponsor
Effexus Pharmaceutical
Collaborators
Southern Arizona VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01129713
Brief Title
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Effexus Pharmaceutical
Collaborators
Southern Arizona VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion
Keywords
GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nexium
Arm Type
Active Comparator
Arm Description
Comparing 40 mg.once daily in healing erosive esophagitis.
Arm Title
Secretol
Arm Type
Active Comparator
Arm Description
Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.
Intervention Type
Drug
Intervention Name(s)
Secretol
Other Intervention Name(s)
lansoprazole/omeprazole combination
Intervention Description
Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
Intervention Type
Drug
Intervention Name(s)
Nexium
Other Intervention Name(s)
Esomeprazole
Intervention Description
Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.
Primary Outcome Measure Information:
Title
Primary objective is to evaluate the relationship between healing and study drug allotment.
Description
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.
Time Frame
3 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronnie Fass, MD
Phone
520-792-1450
Ext
5139
Email
ronnie.fass@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia R. Willis, BS,CCRC
Phone
520-792-1450
Ext
2032
Email
marcia.willis@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Organizational Affiliation
Southern Arizona VA Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona Veterans Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD

12. IPD Sharing Statement

Learn more about this trial

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

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