NCT00247715

Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.

Detailed description

Dyspepsia is very common in the population. On an annual basis, 20%-40% of the general population suffers from upper gastrointestinal symptoms. The prevalence of dyspepsia presenting in primary care is about 3%, on average 24% of these patients are referred for secondary care in the same year. In spite of consensus statements and guidelines, the most effective treatment strategy for managing dyspepsia in primary care remains to be determined. In 2000 the Health Council of the Netherlands published some advice for the Minister of Health, Welfare and Sport with special consideration to the most cost-effective strategies for the management of dyspepsia. The Health Counsel Committee agrees in general with the existing guidelines of the Dutch College of General Practitioners to start with empirical treatment. However, the committee concluded that more research is necessary for management of dyspepsia in primary care, especially in uninvestigated patients as most research has been conducted in patients with persistent dyspeptic symptoms referred for secondary care. Comparison: In this study empirical treatment according to the existing guidelines of the Dutch College of General Practitioners (the step-up treatment strategy) is compared to a step-down treatment strategy. According to this step-down treatment strategy the patient begins treatment with a proton pomp inhibitor, which is an expensive acid-suppressor and is often prescribed by general practitioners. Step-up strategy: Algeldrate-magnesium oxide, in case of persisting/relapsing symptoms continued with ranitidine, if necessary continued with pantoprazole. Step-down strategy: Pantoprazole, in case of persisting or relapsing symptoms continued with ranitidine, if necessary continued with algeldrate-magnesium oxide.

Conditions

• Dyspepsia
• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	algeldrate/magnesium oxide
DRUG	ranitidine
DRUG	pantoprazole

Timeline

• Start date: 2003-10-01
• Completion: 2007-01-01
• First posted: 2005-11-02
• Last updated: 2007-08-29

Locations

3 sites across 1 country: Netherlands