Gastroesophageal RefluxPhase 4GERDNCT00537732
Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
A Phase 4 study testing omeprazole in people with Gastroesophageal Reflux, run by Matthias Schwab at 1 site in Germany.
Trial summary
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Dec 2010
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory
- Range of Age: 20-70
- BMI: 20-30
Who cannot join
- Patients who are allergic to proton-pump inhibitors or show incompatibility
- Patients who have lactase deficiency
- Patients who have severe chronic disease
- Patients who participated in another study during the last three months
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Stuttgart, Baden-Wurttemberg, 70376
About this study
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.
- Conditions
- Gastroesophageal Reflux
- Being tested
- omeprazole
- Keywords
- gastro-oesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazoleDrug
20 mg daily
omeprazoleDrug
20 vs. 60 mg daily, genotype dependent
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 3 tablets, only 20 mg omeprazole, genotype independent Receives: Drug: omeprazole |
| intervention group | Active comparator | 20 vs. 60 mg daily, genotype dependent Receives: Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)
Measured: 4 weeks
Secondary outcomes (1)
clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: recruitment problems
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 Gastroesophageal RefluxStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthias Schwab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Schwab, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Matthias Schwab, Prof, MD, Principal investigator, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537732
- Sponsor's protocol ID
- IKP-219
- Other IDs
- 2006-004650-24
- Acronym
- GERD
- Status last verified
- Feb 2014
- First submitted
- 27 Sep 2007
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. doi: 10.1111/j.1600-0773.2004.pto950102.x.
PubMed 15245569
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
- ClinicalTrials.gov ID
- NCT00537732
- Acronym / sponsor ID
- GERD / IKP-219
- Conditions
- Gastroesophageal Reflux
- Keywords
- gastro-oesophageal reflux disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Matthias SchwabUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Oct 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.
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.
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 |
|---|---|---|
| control group | Active comparator | Drug: omeprazole3 tablets, only 20 mg omeprazole, genotype independent |
| intervention group | Active comparator | Drug: omeprazole20 vs. 60 mg daily, genotype dependent |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory
- Range of Age: 20-70
- BMI: 20-30
Key exclusion criteria (5 listed)
- Patients who are allergic to proton-pump inhibitors or show incompatibility
- Patients who have lactase deficiency
- Patients who have severe chronic disease
- Patients who participated in another study during the last three months
- Patients who are pregnant
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 |
|---|---|---|
| omeprazole20 mg daily | Drug | control group |
| omeprazole20 vs. 60 mg daily, genotype dependent | Drug | intervention group |
Primary outcome
endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)
Time frame: 4 weeks
1 secondary outcome
clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Background: PubMed 15245569Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. doi: 10.1111/j.1600-0773.2004.pto950102.x.
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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.
Matthias Schwab, Prof, MD principal investigator
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
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 omeprazole in people with Gastroesophageal Reflux, run by Matthias Schwab at 1 site in Germany.
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 5 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: stopped early, as of the sponsor's last update on 25 Feb 2014. 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 Germany. 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?
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
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?
endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient) (time frame: 4 weeks). 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 NCT00537732, 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 25 Feb 2014.