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PPI Test in GP Patients

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00318084
First received: April 25, 2006
Last updated: August 15, 2007
Last verified: August 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00318084     History of Changes
Other Study ID Numbers: 25N54
Study First Received: April 25, 2006
Last Updated: August 15, 2007
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:
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013