Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161096
Status:
UNKNOWN
Last Update Posted:
2006-02-02
First Post:
2005-09-08
Brief Title:
On-Demand Use of Pantoprazole Determinants for Chronic Use of Acid Suppressive Medication
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Comparison of the Percentage Chronic on-Demand Users Treated With 20 Mg Pantoprazole on-Demand and Placebo od Versus Placebo on-Demand and 20 Mg Pantoprazole od After Symptom Relief With 20 Mg Pantoprazole od
Status:
UNKNOWN
Status Verified Date:
2004-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 investigate several aspects of chronic use of acid suppressing medication dependence on maintenance therapy the possibilities for on-demand use and predictors patient characteristics for daily need for on-demand use and for termination of chronic use
Detailed Description:
2-5 of the general population is chronic user of acid suppressing medication proton pump inhibitors H2 receptor antagonists mostly because of gastro-oesophageal reflux disease GORD Prescription data from health insurances show that the number of chronic users increases every year which has large economic consequences
There are indications however that on-demand and intermittent therapy can be as effective as daily use No evidence exists regarding patients who are likely to benefit from intermittent on-demand therapy or even termination
In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients
Chronic users are transferred to pantoprazole 20 mg for 4 weeks Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks
group 1 daily pantoprazole 20 mg placebo on-demand indicative for placebo-dependency group 2 daily placebo pantoprazole 20 mg on-demand indicative for pharmacological dependency Patients visit the research nurse at the beginning of the study and at week 4 5 10 and 17
In this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs
Furthermore aspects described in secondary outcomes will be addressed
There are indications however that on-demand and intermittent therapy can be as effective as daily use No evidence exists regarding patients who are likely to benefit from intermittent on-demand therapy or even termination
In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients
Chronic users are transferred to pantoprazole 20 mg for 4 weeks Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks
group 1 daily pantoprazole 20 mg placebo on-demand indicative for placebo-dependency group 2 daily placebo pantoprazole 20 mg on-demand indicative for pharmacological dependency Patients visit the research nurse at the beginning of the study and at week 4 5 10 and 17
In this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs
Furthermore aspects described in secondary outcomes will be addressed
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