Comparison of Nexium VS. Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
Recruitment status was Recruiting
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 60 mg 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 VS. 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 2012|
|Estimated Primary Completion Date:||May 2012 (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 60 mg Secretol once daily in healing erosive esophagitis.
Other Name: Esomeprazole
Active Comparator: Secretol
Comparing the efficacy of 60 mg Secretol once daily in healing erosive esophagitis.
Comparing 60 mg. once daily to Nexium once daily in healing erosive esophagitis.
Other Name: lansoprazole/omeprazole combination
We hypothesize that Secretol 60 mg 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 60 mg 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 email@example.com|
|Contact: Marcia R. Willis, BS,CCRC||520-792-1450 ext firstname.lastname@example.org|
|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|