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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247715
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : August 29, 2007
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dyspepsia Gastrointestinal Diseases Drug: algeldrate/magnesium oxide Drug: ranitidine Drug: pantoprazole Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Step-up

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
step-down

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


Outcome Measures
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Primary Outcome Measures :
  1. Cost-efficacy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Severity of gastrointestinal symptoms [ Time Frame: 2 weeks, after each treatment steps, and 6 months ]
  2. Quality of life [ Time Frame: 2 weeks, after each treatment step, and 6 months ]
  3. Genetic and psychosocial determinants [ Time Frame: baseline and 6 months ]
  4. Patient compliance after treatment [ Time Frame: 0 to 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Maastricht University
Maastricht, Limburg, Netherlands, 6200 MB
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00247715    
Other Study ID Numbers: 945-03-052
CMO 2002/141
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007
Keywords provided by Radboud University Medical Center:
uninvestigated dyspepsia
cost effectiveness
acid suppressive medicine
 primary care
gastrointestinal complaints
Gastrointestinal drugs
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Dyspepsia
Signs and Symptoms, Digestive
Pantoprazole
Ranitidine
Ranitidine bismuth citrate
Magnesium Oxide
Aluminum Hydroxide
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antacids
Adjuvants, Immunologic
Immunologic Factors