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

Sponsored by Effexus Pharmaceutical

About this trial

Last updated 11 years ago

Study ID

NEXIUM versus SECRETOL

Status

Unknown status

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting