PPI Test in GP Patients - Full Text View

Sponsor:	AstraZeneca
Collaborator:	UMC Utrecht
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00318084

Purpose

The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.

Condition	Intervention	Phase
GERD	Drug: Esomeprazole Procedure: Ambulatory 24-hour esophageal pH-monitoring	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.

Secondary Outcome Measures:

To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.
Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test.

Estimated Enrollment:	100
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years
Symptoms suggestive for gastric acid reflux disease during 2 or more days per week

Exclusion Criteria:

Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion
Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion
History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318084

Locations

Netherlands
Research Site
Utrecht, Netherlands

Sponsors and Collaborators

AstraZeneca

UMC Utrecht

Investigators

Study Director:

AstraZeneca Netherlands Medical Director

AstraZeneca

More Information

No publications provided

Study ID Numbers:	25N54
Study First Received:	April 25, 2006
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00318084 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Gastroesophageal reflux disease
Heartburn
Acid-related diseases
Acid reflux disease
Nexium

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010