Viewing Study NCT00295685



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Study NCT ID: NCT00295685
Status: COMPLETED
Last Update Posted: 2009-02-25
First Post: 2006-02-22

Brief Title: Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
Sponsor: Digestive Liver Disease Specialists
Organization: Digestive Liver Disease Specialists

Study Overview

Official Title: Single Dose Nexium 40MG QAM vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study
Status: COMPLETED
Status Verified Date: 2009-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 bid 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 Nexiumhas 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 165 hours of a pH control of 4 Conceivably this duration of pH control suggests that bid dosing of other PPIs might be avoided Furthermore it suggests that patients currently taking bid PPIs might be successful candidates for conversion to qd 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 bid 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None