Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00365300

First received: August 16, 2006

Last updated: April 26, 2010

Last verified: April 2010

History of Changes

Results First Received: November 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Gastroesophageal Reflux
Interventions:	Drug: pantoprazole Drug: Placebo

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 worldwide from September 2006 to August 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for 2 weeks and provided non-pharmacologic conservative therapy including hypoallergenic formula thickened with rice cereal. Patients who improved on this treatment were not eligible for enrollment.

Reporting Groups

Description

Pantoprazole Sodium Granules

Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.

Placebo

Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.

Participant Flow for 2 periods

Period 1: Open-label Phase

	Pantoprazole Sodium Granules	Placebo
STARTED	129	0
COMPLETED	107	0
NOT COMPLETED	22	0
Adverse Event	4	0
Failed to Return	1	0
Physician Decision	1	0
Noncompliance	9	0
Parent/Legal Guardian Request	4	0
Protocol Violation	1	0
Lack of Efficacy	1	0
Patient skipped open label phase	1	0

Period 2: Double-blind Phase

	Pantoprazole Sodium Granules	Placebo
STARTED	54	54
COMPLETED	43	45
NOT COMPLETED	11	9
Failed to return	1	0
Noncompliance	1	1
Withdrawal by Subject	0	1
Protocol Violation	3	1
Lack of Efficacy	6	6

Baseline Characteristics

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Reporting Groups

	Description
Pantoprazole Sodium Granules	Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
Placebo	Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
Total	Total of all reporting groups

Baseline Measures

	Pantoprazole Sodium Granules	Placebo	Total
Number of Participants [units: participants]	52	54	106
Age [units: months] Mean ± Standard Deviation	5.15 ± 2.81	5.04 ± 2.81	5.09 ± 2.80
Gender [units: patients]
Female	18	20	38
Male	34	34	68

Outcome Measures

1. Primary:

Number of Patients Withdrawn From Study Due to Lack of Efficacy. [ Time Frame: 4 weeks double-blind ]

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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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00365300 History of Changes
Other Study ID Numbers:	3001B3-329
Study First Received:	August 16, 2006
Results First Received:	November 30, 2009
Last Updated:	April 26, 2010
Health Authority:	United States: Food and Drug Administration

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