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| Sponsors and Collaborators: |
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00247715 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dyspepsia Gastrointestinal Diseases |
Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| 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) |
| Enrollment: | 664 |
| Study Start Date: | October 2003 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Step-up
Stepwise treatment:
|
Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole |
|
step-down
Stepwise treatment:
|
Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| UMC Utrecht | |
| Utrecht, Netherlands | |
| Netherlands, Gelderland | |
| Radboud University Nijmegen Medical Center | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Netherlands, Limburg | |
| Maastricht University | |
| 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 Medical Center |
| Study Chair: | Andre Knottnerus, MD, PhD | Maastricht University Medical Center |
More Information
| Study ID Numbers: | 945-03-052, CMO 2002/141 |
| Study First Received: | November 1, 2005 |
| Last Updated: | August 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00247715 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
uninvestigated dyspepsia cost effectiveness acid suppressive medicine primary care |
gastrointestinal complaints Gastrointestinal drugs Primary Care |
|
Neurotransmitter Agents Immunologic Factors Signs and Symptoms, Digestive Magnesium Oxide Gastrointestinal Diseases Pantoprazole Adjuvants, Immunologic Dyspepsia Histamine H2 Antagonists Histamine |
Aluminum Hydroxide Signs and Symptoms Ranitidine Digestive System Diseases Histamine Antagonists Ranitidine bismuth citrate Proton Pump Inhibitors Histamine phosphate Antacids |
|
Neurotransmitter Agents Immunologic Factors Signs and Symptoms, Digestive Magnesium Oxide Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Pantoprazole Physiological Effects of Drugs Gastrointestinal Agents Adjuvants, Immunologic Histamine Agents Enzyme Inhibitors |
Dyspepsia Histamine H2 Antagonists Pharmacologic Actions Aluminum Hydroxide Signs and Symptoms Ranitidine Digestive System Diseases Histamine Antagonists Proton Pump Inhibitors Therapeutic Uses Anti-Ulcer Agents Antacids |
