Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251732
Status:
COMPLETED
Last Update Posted:
2010-08-19
First Post:
2005-11-08
Brief Title:
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors PPI
Sponsor:
University of Arizona
Organization:
Southern Arizona VA Health Care System
Study Overview
Official Title:
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose once daily PPI The study will compare the efficacy of 1 standard dose PPI plus low-dose tricyclic antidepressant TCA to 2 double dose PPI to 3 standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups
Detailed Description:
To evaluate the role of pain modulation in gastroesophageal reflux diseaseGERDpatients who fail to obtain clinical relief with standard dose once daily proton pump inhibitorPPI The study will compare the efficacy of 1standard dose PPI plus low-dose tricyclic antidepressant TCA to 2 double dose PPI to 3 standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups
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