Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
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|ClinicalTrials.gov Identifier: NCT00247715|
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : August 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Gastrointestinal Diseases||Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||664 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||October 2003|
|Actual Study Completion Date :||January 2007|
Drug: algeldrate/magnesium oxide
Drug: algeldrate/magnesium oxide
- Cost-efficacy [ Time Frame: 6 months ]
- Severity of gastrointestinal symptoms [ Time Frame: 2 weeks, after each treatment steps, and 6 months ]
- Quality of life [ Time Frame: 2 weeks, after each treatment step, and 6 months ]
- Genetic and psychosocial determinants [ Time Frame: baseline and 6 months ]
- Patient compliance after treatment [ Time Frame: 0 to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247715
|Radboud University Nijmegen Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Maastricht, Limburg, Netherlands, 6200 MB|
|Study Chair:||Jan BMJ Jansen, MD, PhD||Radboud University Nijmegen Medical Center|
|Principal Investigator:||Robert JF Laheij, PhD||Radboud University Nijmegen Medical Center|
|Study Chair:||Niek De Wit, MD, PhD||UMC Utrecht|
|Study Chair:||Mattijs E Numans, MD, PhD||UMC Utrecht|
|Study Chair:||Melvin Samsom, MD, PhD||UMC Utrecht|
|Study Chair:||Jean WM Muris, MD, PhD||Maastricht University|
|Study Chair:||Andre Knottnerus, MD, PhD||Maastricht University|