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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2014 by Effexus Pharmaceutical.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

Southern Arizona VA Health Care System

Information provided by (Responsible Party):

Effexus Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01129713

First received: May 24, 2010

Last updated: August 4, 2014

Last verified: August 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD) Heartburn Indigestion	Drug: Secretol Drug: Nexium	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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).

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Effexus Pharmaceutical:

Primary Outcome Measures:

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.


Estimated Enrollment:	40
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party:	Effexus Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01129713 History of Changes
Other Study ID Numbers:	NEXIUM versus SECRETOL
Study First Received:	May 24, 2010
Last Updated:	August 4, 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 Lansoprazole Esomeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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