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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00526006

Enrollment

Unknown

Registered

2007-09-06

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2007-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI

Brief summary

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.

Interventions

DRUGesomeprazole

40 mg od for 8 wks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Denmark

Contacts

Primary ContactChristina Reimer, MD

rkchre@ra.dk+45 47 32 29 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026