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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00868296




Registration number
NCT00868296
Ethics application status
Date submitted
20/03/2009
Date registered
24/03/2009
Date last updated
4/05/2010

Titles & IDs
Public title
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Scientific title
A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD
Secondary ID [1] 0 0
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
Active comparator: Low dose -

Active comparator: High dose -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Growth Parameters Z-scores
Timepoint [2] 0 0
6 weeks

Eligibility
Key inclusion criteria
* Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.
Minimum age
1 Day
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
58
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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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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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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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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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 provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
Trial website
https://clinicaltrials.gov/study/NCT00868296
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00868296