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

Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129713

Enrollment

Registered

2010-05-25

Start date

2010-05-31

Completion date

2015-05-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion

Keywords

GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion

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.

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.

Interventions

DRUGSecretol

Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.

DRUGNexium

Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary objective is to evaluate the relationship between healing and study drug allotment.	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.

Countries

United States

Contacts

Primary ContactRonnie Fass, MD

ronnie.fass@va.gov520-792-1450

Backup ContactMarcia R. Willis, BS,CCRC

marcia.willis@va.gov520-792-1450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026