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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
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Nebraska
Country [16] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Oklahoma
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Oregon
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United States of America
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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
State/province [31] 0 0
British Columbia
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Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
France
State/province [34] 0 0
Paris Cedex
Country [35] 0 0
Germany
State/province [35] 0 0
Bochum
Country [36] 0 0
Germany
State/province [36] 0 0
Osnabrueck
Country [37] 0 0
Germany
State/province [37] 0 0
Potsdam
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Italy
State/province [38] 0 0
Brescia
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
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Roma
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Netherlands
State/province [41] 0 0
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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South Africa
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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
State/province [50] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00868296