Title

PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms
Study of the Effect of PROGRESSive Withdrawal Esomeprazole of on Acid-related Symptoms, PROGRESS Study A Randomized, Placebo-controlled, Double Blinded Study
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Recruiting
  • Intervention/Treatment

    esomeprazole ...
  • Study Participants

    156
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.
Study Started
Jun 30
2015
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Jan 04
2022

Drug 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.

  • Other names: Nexium®

Other 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.

  • Other names: omeprazole 40mg

Drug Placebo

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

Sudden discontinuation Placebo Comparator

placebo for 7 days

Progressive discontinuation Active Comparator

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

Criteria

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
No Results Posted