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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00362609
Registration number
NCT00362609
Ethics application status
Date submitted
8/08/2006
Date registered
10/08/2006
Date last updated
14/05/2010
Titles & IDs
Public title
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
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Scientific title
A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
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Secondary ID [1]
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3001B3-331, 3001B3-335
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - pantoprazole
Active Comparator: Low dose -
Active Comparator: High dose -
Treatment: Drugs: pantoprazole
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Variance of Oral Bioavailability
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Assessment method [1]
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Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.
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Timepoint [1]
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1 day
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Secondary outcome [1]
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Area Under the Concentration-time Curve (AUC)
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Assessment method [1]
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AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.
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Timepoint [1]
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Baseline to 24 hours post dose on Day 1
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Secondary outcome [2]
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Apparent Oral Clearance (Cl/F)
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Assessment method [2]
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.
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Timepoint [2]
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1 day
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Secondary outcome [3]
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Half Life
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Assessment method [3]
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Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.
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Timepoint [3]
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1 day
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Eligibility
Key inclusion criteria
- Hospitalized patients
- Presumed diagnosis of GERD
- Term or post-term infants within the neonatal period less than 28 days or preterm
infants with a corrected gestational age of less than 44 weeks
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Minimum age
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Maximum age
28
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
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Recruitment hospital [1]
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- Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
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Arizona
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Connecticut
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Germany
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Zurich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Wyeth is now a wholly owned subsidiary of Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether or not consistent drug levels can be
achieved in infants with presumed Gastroesophageal Reflux Disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00362609
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Wyeth is now a wholly owned subsidiary of Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00362609
Download to PDF