Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
The purpose of this study is to determine if people taking lansoprazole two times a day to control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium just once a day.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Single Dose Nexium 40MG QAM vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study|
- The proportion of subjects who are successfully stepped-down to single-dose PPI therapy, defined as having no recurrence of heartburn or acid regurgitation 3 months after PPI step-down.
- Changes in GERD symptom scores, health related quality of life, ancillary medication expenditures, and predictors of successful step-down.
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||December 2007|
approximately 20% of patients taking first generation proton pump inhibitors (PPIs) are taking more than the standard approved dose. This dosing is required to attain adequate control of the gastric and intraesophageal pH in order to affect the desired clinical improvement. It is recognized that the b.i.d dosing strategy increases the intragastric pH control of <4 from approximately 12 hours to almost 16 hours. The refinement of the S isomer of omeprazole (Nexium)has led to a way to more effectively control acid exposure. Comparative trials with all the PPIs have shown significantly greater pH control of <4 and head to head comparisons as well as a recent crossover study. One study suggests that Nexium dosing contains approximately 16.5 hours of a pH control of <4. Conceivably, this duration of pH control suggests that b.i.d. dosing of other PPIs might be avoided. Furthermore, it suggests that patients currently taking b.i.d. PPIs might be successful candidates for conversion to q.d. Nexium. This would provide a considerable cost implication to health care plans and for patients who are responsible for paying for their PPI therapy. To date, esomeprazole has not been studied in comparison to b.i.d. dosing with other PPIs. There is pharmacologic evidence to suggest, however, that it is comparable. In this proposed study, we believe that by beginning with patients who were well controlled should make for a cleaner definition and a higher likelihood to demonstrate efficacy.
|United States, Virginia|
|Digestive & Liver Disease Specialists|
|Norfolk, Virginia, United States, 23502|
|Principal Investigator:||David A Johnson, MD||Digestive & Liver Disease Specialists|