HealthyPhase 4NCT00526006
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
A Phase 4 study testing esomeprazole in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- esomeprazole
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Mar 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years +
Who cannot join
- Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
- Previous treatment with PPI og H2RA
- Previous contact to doctor or hospital because of dyspepsia or reflux
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital Køgw
Køge, 4600
Chrístina Reimer, MD
About this study
The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.
- Conditions
- Healthy
- Being tested
- esomeprazole
- Keywords
- Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
40 mg od for 8 wks
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zealand 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
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christina Reimer, MD, Principal investigator, University Hospital Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526006
- Sponsor's protocol ID
- 2006-00673-145
- Status last verified
- Aug 2007
- First submitted
- 5 Sep 2007
- Last updated
- 6 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
- ClinicalTrials.gov ID
- NCT00526006
- Acronym / sponsor ID
- 2006-00673-145
- Conditions
- Healthy
- Keywords
- Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 6 Sep 2007 (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 acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years +
Key exclusion criteria (4 listed)
- Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
- Previous treatment with PPI og H2RA
- Previous contact to doctor or hospital because of dyspepsia or reflux
- Pregnancy or breast feeding
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 |
|---|---|---|
| esomeprazole40 mg od for 8 wks | Drug | – |
Primary outcome
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2007.
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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.
Christina Reimer, MD principal investigator
University Hospital Køge
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 Healthy, run by Zealand 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 4 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 6 Sep 2007. 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 47 32 29 51, rkchre@ra.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group. 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 6 Sep 2007.