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

NCT00247715 | Completed

• 2 other identifiers: 945-03-052CMO 2002/141
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 3

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.

Conditions

Dyspepsia; Gastrointestinal Diseases

Keywords

uninvestigated dyspepsia; cost effectiveness; acid suppressive medicine; primary care; gastrointestinal complaints; Gastrointestinal drugs

Outcome Measures

Primary Outcomes (1)

• Cost-efficacy

  6 months

Secondary Outcomes (4)

• Severity of gastrointestinal symptoms

  2 weeks, after each treatment steps, and 6 months

• Quality of life

  2 weeks, after each treatment step, and 6 months

• Genetic and psychosocial determinants

  baseline and 6 months

• Patient compliance after treatment

  0 to 6 months

Study Arms (2)

Step-up

OTHER

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

OTHER

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

Interventions

algeldrate/magnesium oxide DRUG

Step-up; step-down

ranitidine DRUG

Step-up; step-down

pantoprazole DRUG

Step-up; step-down

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of prescribed acid suppressive medication during 3 months before consult
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (3)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Maastricht University

Maastricht, Limburg, 6200 MB, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, Netherlands

Location

Related Publications (2)

• 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. doi: 10.1186/1471-2288-7-16.

  PMID: 17451599 BACKGROUND

• 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. doi: 10.1016/S0140-6736(09)60070-2.

  PMID: 19150702 DERIVED

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Interventions

Aluminum Hydroxide; Magnesium Oxide; Ranitidine; Pantoprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes; Magnesium Compounds; Oxides; Oxygen Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jan BMJ Jansen, MD, PhD

  Radboud University Nijmegen Medical Center

  STUDY CHAIR

• Robert JF Laheij, PhD

  Radboud University Nijmegen Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 2, 2005
• Study Start: October 1, 2003
• Study Completion: January 1, 2007
• Last Updated: August 29, 2007

Record last verified: 2007-08

Locations

NL (3)