PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

Zealand University Hospital

Overview

The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Healthy

Interventions

esomeprazoleDRUG

40 mg od for 8 wks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years + Exclusion Criteria: * Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks * Previous treatment with PPI og H2RA * Previous contact to doctor or hospital because of dyspepsia or reflux * Pregnancy or breast feeding

Locations (1)

University Hospital Køgw

Køge, Denmark

RECRUITING

Outcomes

Primary Outcomes

Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group

Central Contacts

Christina Reimer, MD

CONTACT

+45 47 32 29 51 rkchre@ra.dk

Data from ClinicalTrials.gov

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