Trial | NCT01129713  Report issue

Title

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).

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
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.
Study Started
May 31
2010
Primary Completion
May 31
2015
Anticipated
Study Completion
May 31
2015
Anticipated
Last Update
Aug 05
2014
Estimate

Drug Secretol

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

  • Other names: lansoprazole/omeprazole combination

Drug Nexium

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

  • Other names: Esomeprazole

Nexium Active Comparator

Comparing 40 mg.once daily in healing erosive esophagitis.

Secretol Active Comparator

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

Criteria 

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
No Results Posted