Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
Overview[ - collapse ][ - ]
| 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 | Dyspepsia Gastrointestinal Diseases |
| Intervention | Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole |
| Phase | N/A |
| Sponsor | Radboud University |
| Responsible Party | Radboud University |
| ClinicalTrials.gov Identifier | NCT00247715 |
| First Received | November 1, 2005 |
| Last Updated | August 28, 2007 |
| Last verified | August 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 1, 2005 |
|---|---|
| Last Updated Date | August 28, 2007 |
| Start Date | October 2003 |
| Estimated Primary Completion Date | January 2007 |
| Current Primary Outcome Measures | Cost-efficacy [Time Frame: 6 months] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-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) |
| Brief 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 664 |
| Estimated Completion Date | January 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Presence of a new episode of dyspepsia, defined as episodic or persistent symptoms including abdominal pain or discomfort and which are, in the opinion of the general practitioner, referable to the upper gastrointestinal tract. - Over 18 years of age - Informed consent (written) given. Exclusion Criteria: - Use of prescribed acid suppressive medication during 3 months before consult - Investigated by upper gastrointestinal endoscopy one year before inclusion - Malignancy - Contraindication to the study medication - Pregnancy - Alarming symptoms like weight loss, bleeding, and disturbed food passage - Patients with insufficient comprehension of the Dutch language |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00247715 |
|---|---|
| Other Study ID Numbers | 945-03-052 |
| Has Data Monitoring Committee | No |
| Information Provided By | Radboud University |
| Study Sponsor | Radboud University |
| Collaborators | ZonMw: The Netherlands Organisation for Health Research and Development |
| Investigators | Study Chair: Jan BMJ Jansen, MD, PhD Radboud University Nijmegen Medical CenterPrincipal Investigator: Robert JF Laheij, PhD Radboud University Nijmegen Medical CenterStudy Chair: Niek De Wit, MD, PhD UMC UtrechtStudy Chair: Mattijs E Numans, MD, PhD UMC UtrechtStudy Chair: Melvin Samsom, MD, PhD UMC UtrechtStudy Chair: Jean WM Muris, MD, PhD Maastricht UniversityStudy Chair: Andre Knottnerus, MD, PhD Maastricht University |
| Verification Date | August 2007 |
Locations[ + expand ][ + ]
| Radboud University Nijmegen Medical Center | Nijmegen, Gelderland, Netherlands, 6500 HB |
|---|---|
| Maastricht University | Maastricht, Limburg, Netherlands, 6200 MB |
| UMC Utrecht | Utrecht, Netherlands |