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CompletedNCT03467893Updated Aug 6, 2019

Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor in Geriatric Population

An observational study in Proton Pump Inhibitor, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
65 Years and older
Sex
All
01

Study summary

Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. The fact is that multi medication in old patient increase the iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are overused in this patient category.Several studies suggest the existence of a rebound effect when people were treated more than 8 weeks ; this effect seems to appear around 14 days after with hyperacidity symptoms.

But there are no studies about old patient. So in this context the aim of the study is to evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.

02

Conditions studied

  • Proton Pump Inhibitor
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted in Leopold Bellan post acute an rehabilitation institution.

Inclusion criteria

  • patients hospitalized in post acute and rehabilitation service
  • more than 65 years old
  • PPI prescription more than 8 weeks

Exclusion criteria

Exclusion Criteria:

  • PPI prescription under 8 weeks
  • PPI prescription for digestive haemorragy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DrugAntacids

    number aof antacids treatment after PPI stop

05

What researchers measure

Primary outcomes

  1. Number of antacids used

    Time frame: Day 14 after end of treatment

06

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
07

Registry details

Key details

Study ID
NCT03467893
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Jun 10, 2017
Primary completion
Jul 1, 2017
Completion
Feb 28, 2018
Last update
Aug 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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