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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01129713
Other study ID # NEXIUM versus SECRETOL
Secondary ID
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


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
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