|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Digestive & Liver Disease Specialists |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | Digestive & Liver Disease Specialists |
| ClinicalTrials.gov Identifier: | NCT00295685 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
GERD |
Drug: Antacids |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 50 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Virginia | |
| Digestive & Liver Disease Specialists | |
| Norfolk, Virginia, United States, 23502 | |
| Principal Investigator: | David A Johnson, MD | Digestive & Liver Disease Specialists |
More Information
| ClinicalTrials.gov Identifier: | NCT00295685 History of Changes |
| Other Study ID Numbers: | IRUSESOM0159 |
| Study First Received: | February 22, 2006 |
| Last Updated: | February 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Reflux GERD |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Antacids Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |