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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00259012




Registration number
NCT00259012
Ethics application status
Date submitted
23/11/2005
Date registered
28/11/2005
Date last updated
7/05/2010

Titles & IDs
Public title
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Scientific title
A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Secondary ID [1] 0 0
3001B3-333, 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 sodium enteric-coated spheroid suspension

Active comparator: Low dose -

Active comparator: High dose -


Treatment: Drugs: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak Concentration (Cmax)
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Time to Peak Concentration (Tmax) Profile
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Disposition Half-life
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
Area Under the Concentration-time Curve (AUC)
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Apparent Oral Clearance (CL/F)
Timepoint [5] 0 0
1 day
Primary outcome [6] 0 0
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Timepoint [6] 0 0
7 days
Primary outcome [7] 0 0
Intragastric pH
Timepoint [7] 0 0
7 days
Primary outcome [8] 0 0
Median Intragastric pH
Timepoint [8] 0 0
7 days
Primary outcome [9] 0 0
Percentage of Time Intragastric pH Was >4
Timepoint [9] 0 0
7 days
Primary outcome [10] 0 0
Mean Intraesophageal pH
Timepoint [10] 0 0
7 days
Primary outcome [11] 0 0
Median Intraesophageal pH
Timepoint [11] 0 0
7 days
Primary outcome [12] 0 0
Percentage of Time That Intraesophageal pH Was <4
Timepoint [12] 0 0
7 days
Primary outcome [13] 0 0
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Timepoint [13] 0 0
7 days
Primary outcome [14] 0 0
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Timepoint [14] 0 0
7 days

Eligibility
Key inclusion criteria
* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg
Minimum age
1 Month
Maximum age
11 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities

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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
67
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
Arkansas
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
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerpen
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Aachen
Country [19] 0 0
Germany
State/province [19] 0 0
Osnabruck
Country [20] 0 0
Italy
State/province [20] 0 0
Brescia
Country [21] 0 0
Italy
State/province [21] 0 0
Naples
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lodz
Country [25] 0 0
Poland
State/province [25] 0 0
Lublin
Country [26] 0 0
Poland
State/province [26] 0 0
Warszaw
Country [27] 0 0
Switzerland
State/province [27] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nycomed
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
Trial website
https://clinicaltrials.gov/study/NCT00259012
Trial related presentations / publications
Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.
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/NCT00259012