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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease (GERD) Heartburn Indigestion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nexium

Comparing 40 mg.once daily in healing erosive esophagitis.

Group Type ACTIVE_COMPARATOR

Nexium

Intervention Type DRUG

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

Secretol

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

Group Type ACTIVE_COMPARATOR

Secretol

Intervention Type DRUG

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

Interventions

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Secretol

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

Intervention Type DRUG

Nexium

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

Intervention Type DRUG

Other Intervention Names

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lansoprazole/omeprazole combination Esomeprazole

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No