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

August 28, 2007 updated by: Radboud University Medical Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

664

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands
        • UMC Utrecht
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Center
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MB
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Step-up

Stepwise treatment:

  • step1: antacid (+placebo proton pump inhibitor)
  • step2: H2-receptor antagonist
  • step3: proton pump inhibitor (+ placebo antacid)
Drug: pantoprazole
Drug: algeldrate/magnesium oxide
Drug: ranitidine
Other: step-down

Stepwise treatment:

  • step1: proton pump inhibitor (+placebo antacid)
  • step2: H2-receptor antagonist
  • step3: antacid (+proton pump inhibitor)
Drug: pantoprazole
Drug: algeldrate/magnesium oxide
Drug: ranitidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost-efficacy
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of gastrointestinal symptoms
Time Frame: 2 weeks, after each treatment steps, and 6 months
2 weeks, after each treatment steps, and 6 months
Quality of life
Time Frame: 2 weeks, after each treatment step, and 6 months
2 weeks, after each treatment step, and 6 months
Genetic and psychosocial determinants
Time Frame: baseline and 6 months
baseline and 6 months
Patient compliance after treatment
Time Frame: 0 to 6 months
0 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2007

Last Update Submitted That Met QC Criteria

August 28, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 945-03-052
  • CMO 2002/141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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