Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
Gastroesophageal Reflux Disease (GERD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).|
- Primary objective is to evaluate the relationship between healing and study drug allotment. [ Time Frame: 3 weeks of treatment ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Nexium
Comparing 40 mg.once daily in healing erosive esophagitis.
Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.
Other Name: Esomeprazole
Active Comparator: Secretol
Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.
Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
Other Name: lansoprazole/omeprazole combination
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129713
|Contact: Ronnie Fass, MD||520-792-1450 ext firstname.lastname@example.org|
|Contact: Marcia R. Willis, BS,CCRC||520-792-1450 ext email@example.com|
|United States, Arizona|
|Southern Arizona Veterans Health Care System||Recruiting|
|Tucson, Arizona, United States, 85723|
|Principal Investigator: Ronnie Fass, MD|
|Principal Investigator:||Ronnie Fass, MD||Southern Arizona VA Health Care System|