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

Last updated: August 4, 2014
Sponsor: Effexus Pharmaceutical
Overall Status: Trial Status Unknown

Phase

1/2

Condition

Stomach Discomfort

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT01129713
NEXIUM versus SECRETOL
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 periodprior 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

Exclusion Criteria:

  • Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, orpeptic 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, uppergastrointestinal malignancy

  • Women pregnant or lactating

  • History of allergic reaction to any Proton Pump Inhibitor (PPI)

  • Patients can't be treated concurrently with warfarin or otheranticoagulants,salicylates,steroids,NSAIDS > 3 times/week

  • Any medication dependant on gastric acid for optimal absorption

Study Design

Total Participants: 40
Study Start date:
May 01, 2010
Estimated Completion Date:
May 31, 2015

Study 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.

Connect with a study center

  • Southern Arizona Veterans Health Care System

    Tucson, Arizona 85723
    United States

    Active - Recruiting

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