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

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

This study is currently recruiting participants.
Verified by University Hospital Koge, August 2007

Sponsored by:	University Hospital Koge
Information provided by:	University Hospital Koge
ClinicalTrials.gov Identifier:	NCT00526006

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: esomeprazole	Phase IV

ChemIDplus related topics:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:

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

Study Start Date:	September 2007
Estimated Study Completion Date:	March 2008

Intervention Details:

40 mg od for 8 wks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526006

Contacts


Contact: Christina Reimer, MD	+45 47 32 29 51	rkchre@ra.dk

Locations


Denmark
	University Hospital Køgw	Recruiting
	Koge, Denmark, 4600
	Principal Investigator: Chrístina Reimer, MD

Sponsors and Collaborators

University Hospital Koge

Investigators


Principal Investigator:	Christina Reimer, MD	University Hospital Køge

More Information

Study ID Numbers:	2006-00673-145
First Received:	September 5, 2007
Last Updated:	September 5, 2007
ClinicalTrials.gov Identifier:	NCT00526006
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Koge:

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

Study placed in the following topic categories:

Omeprazole

Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008