NCT03467893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

August 6, 2019

Status Verified

March 1, 2018

Enrollment Period

21 days

First QC Date

March 12, 2018

Last Update Submit

August 5, 2019

Conditions

Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Number of antacids used

    Day 14 after end of treatment

Interventions

AntacidsDRUG

number aof antacids treatment after PPI stop

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted in Leopold Bellan post acute an rehabilitation institution.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Antacids

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesGastrointestinal AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 16, 2018

Study Start

June 10, 2017

Primary Completion

July 1, 2017

Study Completion

February 28, 2018

Last Updated

August 6, 2019

Record last verified: 2018-03

Locations

FR(1)