This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

PPI Test in GP Patients

This study has been completed.
UMC Utrecht
Information provided by:
AstraZeneca Identifier:
First received: April 25, 2006
Last updated: August 15, 2007
Last verified: August 2007
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
Intervention Model: Single Group Assignment
Masking: None (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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00318084

Research Site
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Study Director: AstraZeneca Netherlands Medical Director AstraZeneca
  More Information Identifier: NCT00318084     History of Changes
Other Study ID Numbers: 25N54
Study First Received: April 25, 2006
Last Updated: August 15, 2007

Keywords provided by AstraZeneca:
Gastroesophageal reflux disease
Acid-related diseases
Acid reflux disease

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017