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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: algeldrate/magnesium oxide
• Drug: ranitidine
• Drug: pantoprazole

Arms, Groups and Cohorts in this Clinical Trial

• Other: Step-up
  • Stepwise treatment: step1: antacid (+placebo proton pump inhibitor) step2: H2-receptor antagonist step3: proton pump inhibitor (+ placebo antacid)
• Other: step-down
  • Stepwise treatment: step1: proton pump inhibitor (+placebo antacid) step2: H2-receptor antagonist step3: antacid (+proton pump inhibitor)

Primary Measures

• Cost-efficacy
  • Time Frame: 6 months
    

Secondary Measures

• 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
    

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radboud University

Overall Clinical Trial Officials and Contacts

Jan BMJ Jansen, MD, PhD Study Chair Radboud University Nijmegen Medical Center  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247715

Study ID Number: 945-03-052

ClinicalTrials.gov Identifier: NCT00247715

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)