Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629143
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2022-11-03
Brief Title:
Primary carE PPi dEprescRibing Trial
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Determining the Optimal Strategy for Stopping Chronic Proton Pump Inhibitor Therapy in Primary Care Patients Impact of On-demand Use Adjunctive Therapies and Antacids
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PEPPER
Brief Summary:
Proton pump inibitors PPIs is a class of medications that reduce the acid secretion in the stomach These medications are very effective to relieve symptoms of acid reflux for a well-identified group of diseases and conditions
Over the years a major rise in use of these drugs has occurred Convincing analyses reveal that a large share of this use occurs outside regular indications at inappropriately elevated doses and prolonged treatment durations Moreover there are increasing concerns regarding potential adverse effects and the high cost associated with improper PPI use
Guidelines propose to reduce chronic use of PPIs but to date this has not generated a reduction in their application in clinical practice One reason is the occurrence of a period of 2 weeks of increased acid secretion with recurrence of symptoms when these drugs are stopped after already a few weeks of usage rebound effect The best strategy to overcome this period of increased acid secretion and symptoms has not been established
The PEPPER study will evaluate two different strategies to overcome the period of increased secretion when trying to interrupt chronic proton pump inhibitor therapy The investigators will compare the success of stopping PPIs when these strategies are implemented compared to a classical strategy of stopping after intermittent PPI intake The strategies under evaluation are a period of non-daily intake of proton pump inhibitors on-demand before stopping or the use of alternative methods to control gastric acidity and reflux so-called alginates
The investigators will evaluate the success rate of stopping chronic PPIs treatment with these approaches compared to an interruption with intake of antacids Patients will be followed up for 1 year after interruption of PPIs and the level of symptom control quality of life and healthcare costs will be evaluated at intervals
The study will be conducted in patients from primary care practices with chronic PPIs intake outside of the established disease indications
Over the years a major rise in use of these drugs has occurred Convincing analyses reveal that a large share of this use occurs outside regular indications at inappropriately elevated doses and prolonged treatment durations Moreover there are increasing concerns regarding potential adverse effects and the high cost associated with improper PPI use
Guidelines propose to reduce chronic use of PPIs but to date this has not generated a reduction in their application in clinical practice One reason is the occurrence of a period of 2 weeks of increased acid secretion with recurrence of symptoms when these drugs are stopped after already a few weeks of usage rebound effect The best strategy to overcome this period of increased acid secretion and symptoms has not been established
The PEPPER study will evaluate two different strategies to overcome the period of increased secretion when trying to interrupt chronic proton pump inhibitor therapy The investigators will compare the success of stopping PPIs when these strategies are implemented compared to a classical strategy of stopping after intermittent PPI intake The strategies under evaluation are a period of non-daily intake of proton pump inhibitors on-demand before stopping or the use of alternative methods to control gastric acidity and reflux so-called alginates
The investigators will evaluate the success rate of stopping chronic PPIs treatment with these approaches compared to an interruption with intake of antacids Patients will be followed up for 1 year after interruption of PPIs and the level of symptom control quality of life and healthcare costs will be evaluated at intervals
The study will be conducted in patients from primary care practices with chronic PPIs intake outside of the established disease indications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None