Evaluation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication

NCT03980899 | Completed

• 1 other identifier: EGERIPP 2
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome. Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009. Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.

Conditions

Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with one or more of symptoms at Month 3

  Percentage of patients with one or more of the following symptoms at Month 3 after PPI discontinuation: dyspepsia, reflux, heartburn, persistent dry cough, gastralgia (symptoms expected when PPI discontinuation occurs)

  3 months after end of treatment

Secondary Outcomes (5)

• Percentage of patients who have experienced one or more symptoms

  14 days after end of treatment

• Cumulative number of antacid intakes within 14 days of stopping PPIs

  14 days after end of treatment

• Comparaison of percentage

  Day 14 and Month 3

• Proportion of patients who resumed PPI treatment and reason for resumption

  Day 14 and Month 3

• Proportion of patients for whom the use of PPIs and their drug treatments in general is "very high" or "very important"

  Month 3

Study Arms (1)

Patients with PPI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-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
• French-speaking patient
• Patients with PPI\* in their SSRG entry treatment in an indication not recognized by the HAS and which has therefore been stopped (according to the service protocol)

You may not qualify if:

• Patient with a justified indication of PPI (recognized by the HAS)
• Patient receiving an IVSE PPI (pantoprazole 8mg/h) for suspected GI bleeding, even if not proven.
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under the protection of justice
• Patient opposing participation in the study

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

Study Officials

• Bernard P DURAND GASSELIN, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 10, 2019
• Study Start: July 4, 2019
• Primary Completion: November 3, 2020
• Study Completion: April 26, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)