Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01391715
Status:
WITHDRAWN
Last Update Posted:
2012-01-18
First Post:
2011-07-11
Brief Title:
Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD
Sponsor:
Inje University
Organization:
Inje University
Study Overview
Official Title:
Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD a Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
patients could not be recuited within study duration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRNERD
Brief Summary:
To the best of our knowledge there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients Thus we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients
Detailed Description:
In Asian the majority of GERD cases are cases of nonerosive reflux esophagitisNERD NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitisRE In addition the quality of life of NERD patients is quite low NERD patients need quicker and more effective treatment options At present PPI-based step-down treatment is recommended for GERD patients Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26 There are various mechanisms for standard dose PPI failure in GERD patients Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients Patients with the sensitive esophagus normal endoscopy and pH test but positive symptom index were more likely to respond to PPI twice a day It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients
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