Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00373334
First received: September 7, 2006
Last updated: November 17, 2009
Last verified: November 2009
Results First Received: August 3, 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
Conditions: Gastroesophageal Reflux Disease
GERD
Heartburn
Interventions: Drug: nizatidine (axid)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nizatidine 2.5 mg/kg Twice Daily low dose nizatidine plus Conservative Measures
Nizatidine 5.0 mg/kg Twice Daily high dose nizatidine plus Conservative Measures
Placebo

Placebo plus Conservative Measures

Conservative Measures included:

Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure


Participant Flow:   Overall Study
    Nizatidine 2.5 mg/kg Twice Daily     Nizatidine 5.0 mg/kg Twice Daily     Placebo  
STARTED     43     50     45  
COMPLETED     33     32     32  
NOT COMPLETED     10     18     13  



  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.
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Reporting Groups
  Description
Nizatidine 2.5 mg/kg b.i.d. No text entered.
Nizatidine 5.0 mg/kg b.i.d. No text entered.
Conservative Measures Only No text entered.
Total Total of all reporting groups

Baseline Measures
    Nizatidine 2.5 mg/kg b.i.d.     Nizatidine 5.0 mg/kg b.i.d.     Conservative Measures Only     Total  
Number of Participants  
[units: participants]
  43     50     45     138  
Age  
[units: participants]
       
<=18 years     43     50     45     138  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     38     44     38     120  
Male     5     6     7     18  
Region of Enrollment  
[units: participants]
       
United States     43     50     45     138  



  Outcome Measures
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1.  Primary:   Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success   [ Time Frame: 8 weeks ]

2.  Secondary:   Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief   [ Time Frame: 8 weeks ]

3.  Secondary:   Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity   [ Time Frame: 8 weeks ]


  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: Clinical Operations Manager
Organization: Braintree Laboratories, Inc.
phone: 781-843-2202
e-mail: jmcgowan@braintreelabs.com


No publications provided


Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00373334     History of Changes
Other Study ID Numbers: BLI-AX-001
Study First Received: September 7, 2006
Results First Received: August 3, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration