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
  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:


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
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 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:
Proton Pump Inhibitors
Esomeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014