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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
History of Changes
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
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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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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 ]

Measure Type Primary
Measure Title Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
Measure Description The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.
Time Frame 8 weeks  
Safety Issue No  

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.
The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.

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.

Measured Values
    Nizatidine 2.5 mg/kg b.i.d.     Nizatidine 5.0 mg/kg b.i.d.     Conservative Measures Only  
Number of Participants Analyzed  
[units: participants]
 		  42     49     42  
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success  
[units: participants]
 		  27     32     31  


Statistical Analysis 1 for Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
Groups [1] Nizatidine 5.0 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.528
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
Groups [1] Nizatidine 2.5 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.341
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Measure Description Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.
Time Frame 8 weeks  
Safety Issue No  

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.
The analysis population includes all patients that took drug and reached the 8 week study timepoint.

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.

Measured Values
    Nizatidine 2.5 mg/kg b.i.d.     Nizatidine 5.0 mg/kg b.i.d.     Conservative Measures Only  
Number of Participants Analyzed  
[units: participants]
 		  41     44     39  
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief  
[units: participants]
 		     
Better     32     36     29  
No Change     4     2     6  
Worse     5     6     4  


Statistical Analysis 1 for Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Groups [1] Nizatidine 2.5 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Chi-squared
P Value [3] 0.746
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Groups [1] Nizatidine 5.0 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Chi-squared
P Value [3] 0.262
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Measure Description Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.
Time Frame 8 weeks  
Safety Issue No  

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.
The analysis population includes all patients that took drug and reached the 8 week study timepoint.

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.

Measured Values
    Nizatidine 2.5 mg/kg b.i.d.     Nizatidine 5.0 mg/kg b.i.d.     Conservative Measures Only  
Number of Participants Analyzed  
[units: participants]
 		  41     44     38  
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity  
[units: participants]
 		     
None     3     7     5  
Mild     25     26     25  
Moderate     10     9     7  
Severe     3     2     1  


Statistical Analysis 1 for Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Groups [1] Nizatidine 2.5 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Chi-squared
P Value [3] 0.609
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Groups [1] Nizatidine 5.0 mg/kg b.i.d. vs. Conservative Measures Only
Method [2] Chi-squared
P Value [3] 0.938
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  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:
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: 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