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

Heartburn Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01129713
• Other study ID #: NEXIUM versus SECRETOL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 24, 2010
• Last updated: August 4, 2014
• Start date: May 2010
• Est. completion date: May 2015

Study information

• Verified date: August 2014
• Source: Effexus Pharmaceutical
• Contact: Ronnie Fass, MD
• Phone: 520-792-1450
• Email: ronnie.fass[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Heartburn
• Indigestion

Intervention

Drug:
• Secretol
Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
• Nexium
Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.

Locations

Country	Name	City	State
United States	Southern Arizona Veterans Health Care System	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Effexus Pharmaceutical	Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes