DyspepsiaPhase 4NCT00363701
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
A Phase 4 study testing esomeprazole in people with Dyspepsia and Gastroesophageal Refluxdisease, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, Gastroesophageal Refluxdisease, Ulcer
- What is being tested?
- esomeprazole
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Feb 2008
- Phase
- Phase 4
- 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
- Treatment with PPI in at least 4 months out of the preceding 12.
- Use of PPI in the preceding 10 out of 30 days before inclusion
- Age above 18 years
Who cannot join
- Erosive Esophagitis
- PPI-treatment as prophylaxis against gastrointestinal bleeding
- PPI-treatment as prophylaxis against ulcers
- PPI-treatment as prophylaxis because of NSAID-treatment
- Pregnant or lactating women
- Previous upper GI surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of gastroenterology, Glostrup University Hospital
Glostrup Municipality, 2600
Christina Reimer, MD, 43 23 27 79, chrrei01@glostruphosp.kbhamt.dk
About this study
Official title: With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.
Read the detailed description
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.
In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.
Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.
In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.
We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.
An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.
- Conditions
- Dyspepsia, Gastroesophageal Refluxdisease, Ulcer
- Being tested
- esomeprazole
- Keywords
- Protonpumpinhibitors, withdrawal, longterm treatment, dyspepsia, functional dyspepsia, gastrooesophageal reflux, upper endoscopy
- Medical subject headings
- Dyspepsia, Ulcer, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Secondary outcomes (6)
Fraction of patients who are willing to withdraw treatment with PPI
Fraction of patients who experience symptoms after withdrawal of treatment.
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
Length of time from withdrawal till symptoms arise
Correlation between levels of gastrin and CgA and time till symptoms arise
Investigators and patients ability to distinguish between active and placebo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Peter Bytzer, ass. professor, ph.d, Principal investigator, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363701
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2006
- First submitted
- 14 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
- ClinicalTrials.gov ID
- NCT00363701
- Acronym / sponsor ID
- 001
- Conditions
- Dyspepsia, Gastroesophageal Refluxdisease, Ulcer
- Keywords
- Protonpumpinhibitors, withdrawal, longterm treatment, dyspepsia, functional dyspepsia, gastrooesophageal reflux, upper endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Feb 2008
- First posted
- 15 Aug 2006 (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 primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.
Detailed description
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.
In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.
Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.
In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.
We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.
An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment with PPI in at least 4 months out of the preceding 12.
- Use of PPI in the preceding 10 out of 30 days before inclusion
- Age above 18 years
Key exclusion criteria (6 listed)
- Erosive Esophagitis
- PPI-treatment as prophylaxis against gastrointestinal bleeding
- PPI-treatment as prophylaxis against ulcers
- PPI-treatment as prophylaxis because of NSAID-treatment
- Pregnant or lactating women
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 |
|---|---|---|
| esomeprazole | Drug | – |
Primary outcome
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
6 secondary outcomes
Fraction of patients who are willing to withdraw treatment with PPI
Fraction of patients who experience symptoms after withdrawal of treatment.
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
Length of time from withdrawal till symptoms arise
Correlation between levels of gastrin and CgA and time till symptoms arise
Investigators and patients ability to distinguish between active and placebo treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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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.
Peter Bytzer, ass. professor, ph.d principal investigator
Glostrup University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole in people with Dyspepsia and Gastroesophageal Refluxdisease, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Reimer, MD (+45 43 23 27 79, chrrei01@glostruphosp.kbhamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2006.