Recruiting
Phase 1
Phase 2

Nexium vs. Secretol

Sponsor:

Effexus Pharmaceutical

Code:

NCT01129713

Conditions

Gastroesophageal Reflux Disease (GERD)

Heartburn

Indigestion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Secretol

Nexium

Study Details

Brief summary:

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

Conditions

Gastroesophageal Reflux Disease (GERD)

Heartburn

Indigestion

Study ID

NCT01129713

Start date

May, 2010

Status verified date

Aug, 2014

Completion date

May, 2015

Anticipated

Primary completion date

May, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nexium

Comparing 40 mg.once daily in healing erosive esophagitis.

active comparator: Secretol

Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.

Interventions

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.

Primary outcome measure

  • Primary objective is to evaluate the relationship between healing and study drug allotment. [ Time Frame: 3 weeks of treatment ]

Central Contacts and Locations

Central contacts

Ronnie Fass, MD

520-792-1450ronnie.fass@va.gov

Marcia R. Willis, BS,CCRC

520-792-1450marcia.willis@va.gov

Locations

Southern Arizona Veterans Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Principal Investigator:

Ronnie Fass, MD

More Information

Sponsor

Effexus Pharmaceutical

Last update posted

Aug 5, 2014

Last verified

Aug, 2014

Keywords

  • GERD
  • Acid Reflux
  • Heartburn
  • Regurgitation
  • Indigestion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Effexus Pharmaceutical on 2014-08-05.