Gastreoesophageal Reflux DiseasePhase 2NCT00426595
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
A Phase 2 study testing Administration of omeprazole suspension and omeprazole administered as a multi-unit-pellet system in people with Gastreoesophageal Reflux Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gastreoesophageal Reflux Disease
- What is being tested?
- Administration of omeprazole suspension and omeprazole administered as a multi-unit-pellet system
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2007to Nov 2007
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children > 15 kg
- Cerebral palsy and mental retardation with swallowing disorders
- Presence of gastrostomy tube
- GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
- Informed consent
Who cannot join
- Treatment with ciclosporine, tacrolimus, mycofenolate
- Treatment with anticoagulants
- Infection
- Recent start of treatment with known inhibitors of the omeprazole-metabolism
- Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)
Trial locations and contacts
1 site in 1 country.
About this study
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
- Conditions
- Gastreoesophageal Reflux Disease
- Being tested
- Administration of omeprazole suspension, omeprazole administered as a multi-unit-pellet system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of omeprazole suspensionDrug
omeprazole administered as a multi-unit-pellet systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (at the end of the treatment period of 14 days)
Secondary outcomes (1)
Gastric pH (at the end of the treatment period of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastreoesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Myriam Van Winckel, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426595
- Sponsor's protocol ID
- 2007/013
- Status last verified
- Apr 2009
- First submitted
- 23 Jan 2007
- Last updated
- 10 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
- ClinicalTrials.gov ID
- NCT00426595
- Acronym / sponsor ID
- 2007/013
- Conditions
- Gastreoesophageal Reflux Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Jan 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.
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children > 15 kg
- Cerebral palsy and mental retardation with swallowing disorders
- Presence of gastrostomy tube
- GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
- Informed consent
Key exclusion criteria (5 listed)
- Treatment with ciclosporine, tacrolimus, mycofenolate
- Treatment with anticoagulants
- Infection
- Recent start of treatment with known inhibitors of the omeprazole-metabolism
- Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)
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 |
|---|---|---|
| Administration of omeprazole suspension | Drug | – |
| omeprazole administered as a multi-unit-pellet system | Drug | – |
Primary outcome
Pharmacokinetics (at the end of the treatment period of 14 days)
1 secondary outcome
Gastric pH (at the end of the treatment period of 14 days)
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 10 Apr 2009.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Gastreoesophageal Reflux Disease
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
Perioperative Pain Management, Gastreoesophageal Reflux Disease
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.
Myriam Van Winckel, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of omeprazole suspension and omeprazole administered as a multi-unit-pellet system in people with Gastreoesophageal Reflux Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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: finished, as of the sponsor's last update on 10 Apr 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetics (at the end of the treatment period of 14 days). 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 10 Apr 2009.