Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 5, 2014
August 1, 2014
5 years
May 24, 2010
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 weeks of treatment
Study Arms (2)
Nexium
ACTIVE COMPARATORComparing 40 mg.once daily in healing erosive esophagitis.
Secretol
ACTIVE COMPARATORComparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Effexus Pharmaceuticallead
- Southern Arizona VA Health Care Systemcollaborator
Study Sites (1)
Southern Arizona Veterans Health Care System
Tucson, Arizona, 85723, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronnie Fass, MD
Southern Arizona VA Health Care System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 25, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 5, 2014
Record last verified: 2014-08