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Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00259012
First received: November 23, 2005
Last updated: April 19, 2010
Last verified: April 2010
Results First Received: November 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited February 2006 to January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for seven days.

Reporting Groups
  Description
Low Dose Pantoprazole (0.6 mg/kg) Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
High Dose Pantoprazole (1.2 mg/kg) Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.

Participant Flow:   Overall Study
    Low Dose Pantoprazole (0.6 mg/kg)     High Dose Pantoprazole (1.2 mg/kg)  
STARTED     33     34  
COMPLETED     31     30  
NOT COMPLETED     2     4  
Adverse Event                 0                 1  
Withdrawal by Subject                 1                 0  
Physician Decision                 0                 1  
Lost to Follow-up                 0                 1  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose Pantoprazole (0.6 mg/kg) Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
High Dose Pantoprazole (1.2 mg/kg) Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
Total Total of all reporting groups

Baseline Measures
    Low Dose Pantoprazole (0.6 mg/kg)     High Dose Pantoprazole (1.2 mg/kg)     Total  
Number of Participants  
[units: participants]
  33     34     67  
Age  
[units: months]
Mean ± Standard Deviation
  5.98  ± 2.98     5.91  ± 3.42     5.94  ± 3.19  
Gender  
[units: patients]
     
Female     13     15     28  
Male     20     19     39  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Concentration (Cmax)   [ Time Frame: 1 day ]

2.  Primary:   Time to Peak Concentration (Tmax) Profile   [ Time Frame: 1 day ]

3.  Primary:   Disposition Half-life   [ Time Frame: 1 day ]

4.  Primary:   Area Under the Concentration-time Curve (AUC)   [ Time Frame: 1 day ]

5.  Primary:   Apparent Oral Clearance (CL/F)   [ Time Frame: 1 day ]

6.  Primary:   Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration   [ Time Frame: 7 days ]

7.  Primary:   Intragastric pH   [ Time Frame: 7 days ]

8.  Primary:   Median Intragastric pH   [ Time Frame: 7 days ]

9.  Primary:   Percentage of Time Intragastric pH Was >4   [ Time Frame: 7 days ]

10.  Primary:   Mean Intraesophageal pH   [ Time Frame: 7 days ]

11.  Primary:   Median Intraesophageal pH   [ Time Frame: 7 days ]

12.  Primary:   Percentage of Time That Intraesophageal pH Was <4   [ Time Frame: 7 days ]

13.  Primary:   Normalized Area of Gastric Hydrogen Ion Activity Over Time   [ Time Frame: 7 days ]

14.  Primary:   Normalized Area of Esophageal Hydrogen Ion Activity Over Time   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00259012     History of Changes
Other Study ID Numbers: 3001B3-333, 3001B3-335
Study First Received: November 23, 2005
Results First Received: November 30, 2009
Last Updated: April 19, 2010
Health Authority: United States: Food and Drug Administration