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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Effexus Pharmaceutical
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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 ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Effexus Pharmaceutical:
GERD
Acid Reflux
Heartburn
Regurgitation
Indigestion

Additional relevant MeSH terms:
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroesophageal Reflux
Heartburn
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014