An interventional study of algeldrate/magnesium oxide and ranitidine in Dyspepsia and Gastrointestinal Diseases, sponsored by Radboud University Medical Center. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-08-29.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
370 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 664 is above the median of 87 across 303 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Stepwise treatment: * step1: antacid (+placebo proton pump inhibitor) * step2: H2-receptor antagonist * step3: proton pump inhibitor (+ placebo antacid)
Drug: algeldrate/magnesium oxide · Drug: ranitidine · Drug: pantoprazole
Stepwise treatment: * step1: proton pump inhibitor (+placebo antacid) * step2: H2-receptor antagonist * step3: antacid (+proton pump inhibitor)
Drug: algeldrate/magnesium oxide · Drug: ranitidine · Drug: pantoprazole
Drug page: 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
The record gives a start of Oct 2003 and a completion of Jan 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Magnesium Oxide · Ranitidine · Pantoprazole
Radboud University Medical Center →