DyspepsiaPhase 4NCT00120315
Proton Pump Inhibitor Treatment Stop
A Phase 4 study testing esomeprazole and Helicobacter pylori c-13 breath test in people with Dyspepsia, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- esomeprazole and Helicobacter pylori c-13 breath test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2003to Mar 2007
- 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
- Use of antisecretory medication for more than 2 months during the last 6 months
Who cannot join
- Malignity or severe, competing medical or psychiatric disease
- Esophagitis (proven by endoscopy)
- Prior complication to peptic ulcer disease
- Alarm symptoms
- Pregnancy or lactation
- Allergy towards esomeprazole
- Planned hospitalisation during study period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Gastroenterology, Odense University Hospital
Odense, DK-5000
About this study
Official title: Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.
This is evaluated in a discontinuation trial.
Read the detailed description
Background:
Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.
Aim/purpose:
It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.
Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.
Methods:
To conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. Long-term use is defined as treatment for more than 2x28 days during a 6-month period. The patients are included with a 13C-urea Hp-breath test and randomised for treatment with PPI or placebo. Hp-positive patients are treated with an Hp-eradication treatment. The patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. The patients are to fill in a symptom and medication diary every month for periods of 1 week. Questionnaires are to be given to the patients 3 times during the follow-up period. Medication diaries as well as questionnaires have proven useful in similar studies. The main outcome is analysed using Kaplan-Meier survival estimates analysis.
- Conditions
- Dyspepsia
- Being tested
- esomeprazole, Helicobacter pylori c-13 breath test
- Keywords
- dyspepsia, discontinuation, Primary health care, Helicobacter pylori, Proton Pump Inhibitor, Histamine-2-receptor-antagonist
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
esomeprazole, original Nexium, 40 mg pills Up to once a day
Helicobacter pylori c-13 breath testProcedure or surgery
Breath test done at entry to find Helicobacter pylori
| Study group | Role | What they receive |
|---|---|---|
| esomeprazole | No intervention | Long-term users continue antisecretory medication Receives: Drug: esomeprazole; Procedure: Helicobacter pylori c-13 breath test |
| placebo drug | Placebo comparator | Long-term users are treated with placebo Receives: Drug: esomeprazole; Procedure: Helicobacter pylori c-13 breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of patient perceived symptom control despite treatment with project medication
Measured: 12 months
Secondary outcomes (9)
Gastrointestinal symptoms
Measured: 12 months
Quality of life
Measured: 12 months
GPs and patients satisfaction
Measured: 12 months
Helicobacter pylori status
Measured: At enrolement
Resource consumption
Measured: 12 months
Days without symptoms
Measured: 12 months
Use of otc-medication
Measured: 12 months
Sick-leave days
Measured: 12 months
Number of visits to primary and secondary healthcare system
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startDec 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit of General Practice, Odense, University of Southern Denmark, The Danish Medical Research Council, Apotekerfonden af 1991, AstraZeneca, Danish College of General Practitioners
- Investigators
- Ove B Schaffalitzky de Muckadell, Professor, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120315
- Sponsor's protocol ID
- 2612-2176
- Other IDs
- MPU 16-2003, D9612L00060, 02.04, VF 20020212
- Status last verified
- Oct 2009
- First submitted
- 8 Jul 2005
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Zwisler JE, Jarbol DE, Lassen AT, Kragstrup J, Thorsgaard N, Schaffalitzky de Muckadell OB. Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice. Int J Family Med. 2015;2015:175436. doi: 10.1155/2015/175436. Epub 2015 Jul 12.
PubMed 26246908
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
- ClinicalTrials.gov ID
- NCT00120315
- Acronym / sponsor ID
- 2612-2176
- Conditions
- Dyspepsia
- Keywords
- dyspepsia, discontinuation, Primary health care, Helicobacter pylori, Proton Pump Inhibitor, Histamine-2-receptor-antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Research Unit of General Practice, Odense, University of Southern Denmark, The Danish Medical Research Council, Apotekerfonden af 1991, AstraZeneca, Danish College of General Practitioners
- Study start
- Dec 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 15 Jul 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 is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.
This is evaluated in a discontinuation trial.
Detailed description
Background:
Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.
Aim/purpose:
It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.
Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.
Methods:
To conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. Long-term use is defined as treatment for more than 2x28 days during a 6-month period. The patients are included with a 13C-urea Hp-breath test and randomised for treatment with PPI or placebo. Hp-positive patients are treated with an Hp-eradication treatment. The patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. The patients are to fill in a symptom and medication diary every month for periods of 1 week. Questionnaires are to be given to the patients 3 times during the follow-up period. Medication diaries as well as questionnaires have proven useful in similar studies. The main outcome is analysed using Kaplan-Meier survival estimates analysis.
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 |
|---|---|---|
| esomeprazole | No intervention | Drug: esomeprazole, Procedure: Helicobacter pylori c-13 breath testLong-term users continue antisecretory medication |
| placebo drug | Placebo comparator | Drug: esomeprazole, Procedure: Helicobacter pylori c-13 breath testLong-term users are treated with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Use of antisecretory medication for more than 2 months during the last 6 months
Key exclusion criteria (7 listed)
- Malignity or severe, competing medical or psychiatric disease
- Esophagitis (proven by endoscopy)
- Prior complication to peptic ulcer disease
- Alarm symptoms
- Pregnancy or lactation
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 |
|---|---|---|
| esomeprazoleesomeprazole, original Nexium, 40 mg pills Up to once a day | Drug | esomeprazole, placebo drug |
| Helicobacter pylori c-13 breath testBreath test done at entry to find Helicobacter pylori | Procedure or surgery | esomeprazole, placebo drug |
Primary outcome
Failure of patient perceived symptom control despite treatment with project medication
Time frame: 12 months
9 secondary outcomes
Gastrointestinal symptoms
Time frame: 12 months
Quality of life
Time frame: 12 months
GPs and patients satisfaction
Time frame: 12 months
Helicobacter pylori status
Time frame: At enrolement
Resource consumption
Time frame: 12 months
Days without symptoms
Time frame: 12 months
Use of otc-medication
Time frame: 12 months
Sick-leave days
Time frame: 12 months
Number of visits to primary and secondary healthcare system
Time frame: 12 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 6 Oct 2009.
- Derived from this study: PubMed 26246908Zwisler JE, Jarbol DE, Lassen AT, Kragstrup J, Thorsgaard N, Schaffalitzky de Muckadell OB. Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice. Int J Family Med. 2015;2015:175436. doi: 10.1155/2015/175436. Epub 2015 Jul 12.
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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.
Ove B Schaffalitzky de Muckadell, Professor study director
Odense 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 and Helicobacter pylori c-13 breath test in people with Dyspepsia, run by Odense University Hospital 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 1 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 6 Oct 2009. 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. Some participants in this study may receive a placebo. 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?
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?
Failure of patient perceived symptom control despite treatment with project medication (time frame: 12 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 NCT00120315, which also lists 1 linked publication.
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 6 Oct 2009.