PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2023-12-31

Brief Summary

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Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn, acid regurgitation, or dyspepsia that might result in resumption of therapy. A plausible physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH caused by blockage of the proton-pumps stimulates compensatory gastrin release. Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who had received eight weeks of esomperazole. The clinical symptoms occured in a different prevalence compared with placebo treated patients at ten weeks after withdrawal and until the end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients likely to benefit from it.

In this context, we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden discontinuation of esomeprazole 40mg.

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Detailed Description

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Conditions

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Stomach Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sudden discontinuation

placebo for 7 days

Group Type PLACEBO_COMPARATOR

CYP2C19 phenotypical analysis

Intervention Type OTHER

All patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study.

Placebo

Intervention Type DRUG

Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.

Progressive discontinuation

Esomeprazole: Nexium® 20mg, Astra Zeneca , for 7 days

Group Type ACTIVE_COMPARATOR

Esomeprazole: Nexium® 20mg, Astra Zeneca

Intervention Type DRUG

Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.

CYP2C19 phenotypical analysis

Intervention Type OTHER

All patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study.

Interventions

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Esomeprazole: Nexium® 20mg, Astra Zeneca

Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.

Intervention Type DRUG

CYP2C19 phenotypical analysis

All patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study.

Intervention Type OTHER

Placebo

Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.

Intervention Type DRUG

Other Intervention Names

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Nexium® omeprazole 40mg

Eligibility Criteria

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Inclusion Criteria

* Treatment by esomeprazole 40mg since 4 weeks or more
* Esomeprazole withdrawal decided by the clinician
* Male and female aged 18-90 years
* Volunteers to participate to the study
* Must understand and read French language
* Must be able to give a written informed consent

Exclusion Criteria

* Impairment of cognitive status
* Current indication to continue PPI treatment
* History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome
* Short-term treatment of documented ulcer disease, as part of a combination regimen for Helicobacter pylori (HP) eradication
* Prevention of ulcers due to non-steroidal anti-inflammatory drugs.
* Hepatic impairment (TP\<60%)
* Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole
* Current pregnancy or current breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No