Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236392
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-10-07
Brief Title:
A Study of Efficacy and Safety of On-demand Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease NERD
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Double-Blind Placebo-Controlled Randomized Withdrawal Trial Assessing the Efficacy and Tolerability of On-Demand Maintenance Therapy With 10mg od Rabeprazole for 6 Months in Non-Erosive Reflux Disease Patients With Complete Symptom Relief After 4 Week Open Acute Phase
Status:
COMPLETED
Status Verified Date:
2010-11
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 purpose of this study is to assess the efficacy and safety of long-term on-demand maintenance therapy with rabeprazole in patients with non-erosive reflux disease NERD
Detailed Description:
More than half of patients with typical gastroesophageal reflux symptoms such as heartburn are considered to have non-erosive reflux disease NERD which is characterized by a lack of clinically defined damage to the esophagus One approach to maintain control of these symptoms is to have medication available on-demand This is a double-blind placebo-controlled study of the effectiveness of on-demand rabeprazole in the long-term maintenance of heartburn control in NERD patients for whom heartburn was resolved with short-term daily rabeprazole therapy The study has two phases an acute phase 4 weeks during which patients receive rabeprazole medication daily and an on-demand phase 6 months during which patients take medication rabeprazole or placebo as needed Only patients who have complete resolution of heartburn at the end of the acute phase are eligible to continue in the on-demand phase Efficacy assessments include the proportion of patients discontinuing treatment in the on-demand phase because of insufficient heartburn control and the severity of heartburn and patient satisfaction determined at the beginning and end of on-demand phase Safety assessments include incidence of adverse events throughout the study physical examination at study initiation and vital signs at the beginning and the end of the study The study hypothesis is that on-demand therapy with rabeprazole is superior to placebo in maintaining heartburn control and is well tolerated by the patients with NERD Rabeprazole tablet 10 milligramsmg once daily in the morning for 4 weeks Rabeprazole tablets 10mg once daily on an on-demand basis for the following 6 months
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