Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] (BATT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00094328
First received: October 16, 2004
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: May 19, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Puberty, Precocious
Interventions: Drug: Bicalutamide
Drug: Anastrozole

  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
The first patient was enrolled on 22 November 2004 and the last patient completed the 12 months visit on 22 May 2008. Patients were allocated treatment at 9 centers in 3 countries: India, the UK and the USA. Care for two patients, transferred from one US to a new approved US centre, therefore, patients were treated at 10 centers in total.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 21 patients enrolled, 7 failed eligibility criteria and were classed as screening failures while the remaining 14 patients were allocated treatment.

Reporting Groups
  Description
Open Label Bicalutamide With Anastrozole Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently

Participant Flow:   Overall Study
    Open Label Bicalutamide With Anastrozole  
STARTED     14 [1]
COMPLETED     13 [2]
NOT COMPLETED     1  
Lost to Follow-up                 1  
[1] Received treatment
[2] Completed 12 months on treatment



  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
Open Label Bicalutamide With Anastrozole Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently

Baseline Measures
    Open Label Bicalutamide With Anastrozole  
Number of Participants  
[units: participants]
  14  
Age  
[units: Years]
Median ( Full Range )
  3.5  
  ( 2 to 9 )  
Gender  
[units: Participants]
 
Female     0  
Male     14  
Race/Ethnicity, Customized  
[units: Participants]
 
Caucasian     12  
Black     1  
Other     1  
Race/Ethnicity, Customized  
[units: Participants]
 
Hispanic/Latino     1  
African/American     1  
Asian     3  
Not Applicable     9  



  Outcome Measures
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1.  Primary:   Change in Growth Rate (cm/Year)   [ Time Frame: Assessed after 12 months treatment ]

2.  Primary:   Change in Growth Rate (SD Units)   [ Time Frame: Assessed after 12 months treatment ]

3.  Secondary:   Change in Bone Maturation Rate   [ Time Frame: Assessed after 12 months treatment ]

4.  Secondary:   Normalization of Growth Rate   [ Time Frame: Assessed after 12 months treatment ]

5.  Secondary:   Change in Predicted Adult Height (PAH)   [ Time Frame: Assessed after 12 months treatment ]


  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: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00094328     History of Changes
Other Study ID Numbers: D6873C00047, BATT
Study First Received: October 16, 2004
Results First Received: May 19, 2009
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration