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
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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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
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 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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


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