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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
3001B3-331, 3001B3-335
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pantoprazole

Active Comparator: Low dose -

Active Comparator: High dose -


Treatment: Drugs: pantoprazole


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Variance of Oral Bioavailability - 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.
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Area Under the Concentration-time Curve (AUC) - 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.
Timepoint [1] 0 0
Baseline to 24 hours post dose on Day 1
Secondary outcome [2] 0 0
Apparent Oral Clearance (Cl/F) - 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.
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Half Life - 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.
Timepoint [3] 0 0
1 day

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
Minimum age
No limit
Maximum age
28 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- cardiovascular instability

- clinically significant laboratory abnormalities

- use of warfarin, carbamazepine, phenytoin, or rifampin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
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Arizona
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California
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Nebraska
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New Jersey
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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West Virginia
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United States of America
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Wisconsin
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Belgium
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Edegem
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Paris Cedex
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Germany
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Bochum
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Germany
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Osnabrueck
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Germany
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Potsdam
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Italy
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Brescia
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Italy
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Napoli
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Italy
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Roma
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Netherlands
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Rotterdam
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Poland
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Bydgoszcz
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Poland
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Krakow
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Lublin
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CPT
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South Africa
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KZN
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South Africa
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Durban
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South Africa
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Overport
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South Africa
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Pretoria
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Switzerland
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Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00362609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications