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

This study has been completed.

Study NCT00259012 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on November 23, 2005. Last Updated on April 19, 2010 History of Changes

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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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.

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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

Disposition Half-life [ Time Frame: 1 day ]

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

Intragastric pH [ Time Frame: 7 days ]

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8. Primary:

Median Intragastric pH [ Time Frame: 7 days ]

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9. Primary:

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

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10. Primary:

Mean Intraesophageal pH [ Time Frame: 7 days ]

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11. Primary:

Median Intraesophageal pH [ Time Frame: 7 days ]

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12. Primary:

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

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13. Primary:

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

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14. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

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
No text entered.

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:

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 1;50(8):541-50.

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