DyspepsiaNCT00247715
Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
A study testing algeldrate/magnesium oxide, ranitidine and pantoprazole in people with Dyspepsia and Gastrointestinal Diseases, run by Radboud University Medical Center at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, Gastrointestinal Diseases
- What is being tested?
- algeldrate/magnesium oxide, ranitidine and pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2003to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Maastricht University
Maastricht, Limburg, 6200 MB
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
UMC Utrecht
Utrecht, Utrecht
About this study
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.
Read the 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.
- Conditions
- Dyspepsia, Gastrointestinal Diseases
- Being tested
- algeldrate/magnesium oxide, ranitidine, pantoprazole
- Keywords
- uninvestigated dyspepsia, cost effectiveness, acid suppressive medicine, primary care, gastrointestinal complaints, Gastrointestinal drugs
- Medical subject headings
- Dyspepsia, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
algeldrate/magnesium oxideDrug
ranitidineDrug
pantoprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Step-up | Other | Stepwise treatment:
* step1: antacid (+placebo proton pump inhibitor)
* step2: H2-receptor antagonist
* step3: proton pump inhibitor (+ placebo antacid) Receives: 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) Receives: Drug: algeldrate/magnesium oxide; Drug: ranitidine; Drug: pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-efficacy
Measured: 6 months
Secondary outcomes (4)
Severity of gastrointestinal symptoms
Measured: 2 weeks, after each treatment steps, and 6 months
Quality of life
Measured: 2 weeks, after each treatment step, and 6 months
Genetic and psychosocial determinants
Measured: baseline and 6 months
Patient compliance after treatment
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startOct 2003
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Jan BMJ Jansen, MD, PhD, Study chair, Radboud University Nijmegen Medical CenterRobert JF Laheij, PhD, Principal investigator, Radboud University Nijmegen Medical CenterNiek De Wit, MD, PhD, Study chair, UMC UtrechtMattijs E Numans, MD, PhD, Study chair, UMC UtrechtMelvin Samsom, MD, PhD, Study chair, UMC UtrechtJean WM Muris, MD, PhD, Study chair, Maastricht UniversityAndre Knottnerus, MD, PhD, Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247715
- Sponsor's protocol ID
- 945-03-052
- Other IDs
- CMO 2002/141
- Status last verified
- Aug 2007
- First submitted
- 1 Nov 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1186/1471-2288-7-16.
PubMed 17451599van 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.
PubMed 19150702
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00247715
- Acronym / sponsor ID
- 945-03-052
- Conditions
- Dyspepsia, Gastrointestinal Diseases
- Keywords
- uninvestigated dyspepsia, cost effectiveness, acid suppressive medicine, primary care, gastrointestinal complaints, Gastrointestinal drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Oct 2003
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step-up | Other | Drug: algeldrate/magnesium oxide, Drug: ranitidine, Drug: pantoprazoleStepwise treatment: * step1: antacid (+placebo proton pump inhibitor) * step2: H2-receptor antagonist * step3: proton pump inhibitor (+ placebo antacid) |
| step-down | Other | Drug: algeldrate/magnesium oxide, Drug: ranitidine, Drug: pantoprazoleStepwise treatment: * step1: proton pump inhibitor (+placebo antacid) * step2: H2-receptor antagonist * step3: antacid (+proton pump inhibitor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| algeldrate/magnesium oxide | Drug | Step-up, step-down |
| ranitidine | Drug | Step-up, step-down |
| pantoprazole | Drug | Step-up, step-down |
Primary outcome
Cost-efficacy
Time frame: 6 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2007.
- Background: PubMed 17451599Fransen 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.
- Derived from this study: PubMed 19150702van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan BMJ Jansen, MD, PhD study chair
Radboud University Nijmegen Medical Center
Robert JF Laheij, PhD principal investigator
Radboud University Nijmegen Medical Center
Niek De Wit, MD, PhD study chair
UMC Utrecht
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing algeldrate/magnesium oxide, ranitidine and pantoprazole in people with Dyspepsia and Gastrointestinal Diseases, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-efficacy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247715, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2007.