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

April 25, 2006
August 15, 2007
January 2003
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00318084 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
PPI Test in GP Patients
The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
GERD
  • Drug: Esomeprazole
  • Procedure: Ambulatory 24-hour esophageal pH-monitoring
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00318084
25N54
Not Provided
Not Provided
AstraZeneca
UMC Utrecht
Study Director: AstraZeneca Netherlands Medical Director AstraZeneca
AstraZeneca
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP