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

Dyspepsia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247715
• Other study ID #: 945-03-052
• Secondary ID: CMO 2002/141
• Status: Completed
• Phase: N/A
• First received: November 1, 2005
• Last updated: August 28, 2007
• Start date: October 2003
• Est. completion date: January 2007

Study information

• Verified date: August 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Gastrointestinal Diseases

Intervention

Drug:
• algeldrate/magnesium oxide

• ranitidine

• pantoprazole

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-efficacy		6 months
Secondary	Severity of gastrointestinal symptoms		2 weeks, after each treatment steps, and 6 months
Secondary	Quality of life		2 weeks, after each treatment step, and 6 months
Secondary	Genetic and psychosocial determinants		baseline and 6 months
Secondary	Patient compliance after treatment		0 to 6 months