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

Sponsor:	Radboud University
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Histamine Aluminum hydroxide Ranitidine Ranitidine Hydrochloride Pantoprazole Ranitidine bismuth citrate Pantoprazole Sodium Magnesium oxide Algeldrate Magnesium

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Cost-efficacy [ Time Frame: 6 months ]

Secondary Outcome 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 ]

Enrollment:	664
Study Start Date:	October 2003
Study Completion Date:	January 2007

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247715

Locations

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

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

More Information

Publications:

Fransen GA, van Marrewijk CJ, Mujakovic S, Muris JW, Laheij RJ, Numans ME, de Wit NJ, Samsom M, Jansen JB, Knottnerus JA. Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study. BMC Med Res Methodol. 2007 Apr 23;7:16. Review.

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

van Marrewijk CJ, Mujakovic S, Fransen GA, Numans ME, de Wit NJ, Muris JW, van Oijen MG, Jansen JB, Grobbee DE, Knottnerus JA, Laheij RJ. Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial. Lancet. 2009 Jan 17;373(9659):215-25.

ClinicalTrials.gov Identifier:	NCT00247715 History of Changes
Other Study ID Numbers:	945-03-052, CMO 2002/141
Study First Received:	November 1, 2005
Last Updated:	August 28, 2007
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

uninvestigated dyspepsia
cost effectiveness
acid suppressive medicine
primary care

gastrointestinal complaints
Gastrointestinal drugs
Primary Care

Additional relevant MeSH terms:

Dyspepsia
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Diseases
Aluminum Hydroxide
Antacids
Magnesium Oxide
Ranitidine bismuth citrate
Pantoprazole
Gastrointestinal Agents
Ranitidine
Histamine H2 Antagonists

Proton Pump Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Anti-Ulcer Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012