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

Effexus Pharmaceutical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Heartburn; Indigestion; Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Nexium; Drug: Secretol

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01129713

NEXIUM versus SECRETOL

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Nexium

Active Comparator group

Description:

Comparing 40 mg.once daily in healing erosive esophagitis.

Treatment:

Drug: Nexium

Secretol

Active Comparator group

Description:

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

Treatment:

Drug: Secretol