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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00868296
Ethics application status
Date submitted
20/03/2009
Date registered
23/03/2009
Date last updated
29/04/2010

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
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
Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period - Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium = 3.0 mEq/L or = 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin = 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Growth Parameters Z-scores - Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
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
No limit
Maximum age
12 Months
Gender
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
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
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Vermont
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
West Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Belgium
State/province [29] 0 0
Edegem
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
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
Country [38] 0 0
Italy
State/province [38] 0 0
Brescia
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Netherlands
State/province [41] 0 0
Rotterdam
Country [42] 0 0
Poland
State/province [42] 0 0
Bydgoszcz
Country [43] 0 0
Poland
State/province [43] 0 0
Krakow
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
South Africa
State/province [45] 0 0
CPT
Country [46] 0 0
South Africa
State/province [46] 0 0
KZN
Country [47] 0 0
South Africa
State/province [47] 0 0
Durban
Country [48] 0 0
South Africa
State/province [48] 0 0
Overport
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria
Country [50] 0 0
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
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/show/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
Other publications