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OpenTrials
Completed

NCT Number: NCT00318084

PPI Test in GP 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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Ambulatory 24-hour esophageal pH-monitoring

Procedure

Primary outcomes

  1. 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 outcomes

  1. To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • UMC Utrecht

Registry information

Official study title

The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

Important dates

Study start
2003
First posted
Apr 26, 2006
Registry last updated
Aug 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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