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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
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/NCT00259012