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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
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
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Area Under the Concentration-time Curve (AUC)
Timepoint [1] 0 0
Baseline to 24 hours post dose on Day 1
Secondary outcome [2] 0 0
Apparent Oral Clearance (Cl/F)
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Half Life
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
1 Day
Maximum age
28 Days
Sex
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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
59
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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United States of America
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Arizona
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California
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Connecticut
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United States of America
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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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United States of America
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Idaho
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Illinois
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Kentucky
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Louisiana
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Maryland
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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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Poland
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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/ct2/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