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

October 16, 2004
August 14, 2014
November 2004
May 2008   (final data collection date for primary outcome measure)
  • Change in Growth Rate (cm/Year) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
  • Change in Growth Rate (SD Units) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).
Not Provided
Complete list of historical versions of study NCT00094328 on ClinicalTrials.gov Archive Site
  • Change in Bone Maturation Rate [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 months and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation was calculated from this rate and that calculated at 12 months.
  • Normalization of Growth Rate [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.
  • Change in Predicted Adult Height (PAH) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    Radiographs will be used to assess the bone age, the PAH is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH will be calculated by subtracting the PAH at baseline from the PAH at 12 months.
Not Provided
Not Provided
Not Provided
 
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis

The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Puberty, Precocious
  • Drug: Bicalutamide
    oral
    Other Name: Casodex
  • Drug: Anastrozole
    oral
    Other Names:
    • Arimidex
    • ZD1033
Bicalutamide with Anastrozole
Bicalutamide in combination with Anastrozole
Interventions:
  • Drug: Bicalutamide
  • Drug: Anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
August 2017
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements)
  • Male aged 2 years and over
  • Diagnosis of testotoxicosis based on the following:
  • Clinical features of Progressive sexual precocity documented by Tanner staging and evidence of symmetrical testicular enlargement
  • Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age)
  • Pubertal levels of serum testosterone
  • Prepubertal levels of serum gonadotropins
  • Lack of an increase in serum gonadotropin levels following GnRH stimulation
  • Other pathology excluded by:
  • Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below the LOQ will be reported as "<10 IU/L" which in the clinical setting equate to 'undetectable'.
  • Normal levels of 17-hydroxyprogesterone (17-OHP)
  • Normal levels of dehydroepiandrosterone sulphate (DHEAS)
  • Naive to anti androgen receptor therapy:

(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)

  • A documented reliable height measurement taken > 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.

(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and > 6 months prior to study entry)

  • Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis.

Exclusion Criteria:

  • Evidence of central precocious puberty as demonstrated by GnRH stimulation test
  • Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age
  • Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age
  • Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance
  • Known hypersensitivity to any of the study medications
  • Participation in a clinical study at the time of enrollment
Male
2 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   India,   Russian Federation,   United Kingdom
 
NCT00094328
D6873C00047, BATT
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Yuri E Rukazenkov, MD AstraZeneca
AstraZeneca
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP