GERDPhase 1NCT00747695
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, Inclusive
A Phase 1 study testing Rabeprazole sodium in people with GERD, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in children between the ages of 1 and 11 years, inclusive, with GERD. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- GERD
- What is being tested?
- Rabeprazole sodium
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 1
- 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 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boy and girls and a minimum weight of 10 kg with endoscopically proven GERD including an endoscopic examination as part of their diagnostic evaluation
- Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off antacids for 24 hours, and PPIs and H2 blockers for 3 days prior to dosing, except for cimetidine, which must be discontinued for at least 7 days prior to dosing) and remain off these medications for the treatment period
- Patients who are generally healthy, other than the presence of GERD, with the exception of the following: Patients with stable asthma/reactive airway disease or cystic fibrosis-dependent GERD symptoms on stable treatment regimens or subjects on stable doses of allergy and attention deficit disorder medicines.
Who cannot join
- Patients who have a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Primary pulmonary or ENT symptoms
- Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
- History of primary esophageal motility disorders or systemic condition affecting the esophagus
- History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy
- History of or current presence of peptic ulcers
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- Current presence of Helicobacter pylori
- History of definitive acid-lowering surgery
- Significant arrhythmias.
About this study
Official title: A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With GERD 1 to 11 Years Old, Inclusive
The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in children between the ages of 1 and 11 years, inclusive, with GERD.
Read the detailed description
This is an open-label (both the physician and the patient know the name of the study medication), multi-center, Phase 1 study, consisting of 2 parts. The first part of the study will be non-randomized, all patients will receive the same dose. In the second part of the study, patients will be randomized (study medication assigned by chance) into 2 dose groups. The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics (clinical global impressions and formulation palatability) and safety of rabrepazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 years, inclusive, with GERD. As this study is an exploratory assessment of the pharmacokinetics, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied. Safety and tolerability, including monitoring of adverse events, clinical laboratory results, physical examination, vital signs and ECG measurements, will be evaluated throughout the study. Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days as a bead formulation. Patients in the first part of the study will receive single and multiple daily every 24 hours doses of 0.14 mg/kg, using increments of 1 mg dose. Safety and pk data from part 1 of the study will determine the 2 dosages to be studied in part 2 of the study.
- Conditions
- GERD
- Being tested
- Rabeprazole sodium
- Keywords
- Pediatric Pharmacokinetics, Pediatric Pharmacodynamics, Rabeprazole, Pediatric GERD, Aciphex
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startMar 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747695
- Sponsor's protocol ID
- CR013945
- Status last verified
- Jan 2011
- First submitted
- 4 Sep 2008
- Last updated
- 10 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With GERD 1 to 11 Years Old, Inclusive
- ClinicalTrials.gov ID
- NCT00747695
- Acronym / sponsor ID
- CR013945
- Conditions
- GERD
- Keywords
- Pediatric Pharmacokinetics, Pediatric Pharmacodynamics, Rabeprazole, Pediatric GERD, Aciphex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study start
- Mar 2008
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Sep 2008 (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 the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in children between the ages of 1 and 11 years, inclusive, with GERD.
Detailed description
This is an open-label (both the physician and the patient know the name of the study medication), multi-center, Phase 1 study, consisting of 2 parts. The first part of the study will be non-randomized, all patients will receive the same dose. In the second part of the study, patients will be randomized (study medication assigned by chance) into 2 dose groups. The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics (clinical global impressions and formulation palatability) and safety of rabrepazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 years, inclusive, with GERD. As this study is an exploratory assessment of the pharmacokinetics, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied. Safety and tolerability, including monitoring of adverse events, clinical laboratory results, physical examination, vital signs and ECG measurements, will be evaluated throughout the study. Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days as a bead formulation. Patients in the first part of the study will receive single and multiple daily every 24 hours doses of 0.14 mg/kg, using increments of 1 mg dose. Safety and pk data from part 1 of the study will determine the 2 dosages to be studied in part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boy and girls and a minimum weight of 10 kg with endoscopically proven GERD including an endoscopic examination as part of their diagnostic evaluation
- Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off antacids for 24 hours, and PPIs and H2 blockers for 3 days prior to dosing, except for cimetidine, which must be discontinued for at least 7 days prior to dosing) and remain off these medications for the treatment period
- Patients who are generally healthy, other than the presence of GERD, with the exception of the following: Patients with stable asthma/reactive airway disease or cystic fibrosis-dependent GERD symptoms on stable treatment regimens or subjects on stable doses of allergy and attention deficit disorder medicines.
Key exclusion criteria (9 listed)
- Patients who have a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Primary pulmonary or ENT symptoms
- Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
- History of primary esophageal motility disorders or systemic condition affecting the esophagus
- History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy
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 |
|---|---|---|
| Rabeprazole sodium | Drug | – |
Primary outcome
Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.
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 Jan 2011.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rabeprazole sodium in people with GERD, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 9 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.. 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 Jan 2011.