Clinical Trial: Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: 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 .

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

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

Original Primary Outcome:

Current Secondary Outcome:

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

Original Secondary Outcome:

Information By: AstraZeneca

Dates:
Date Received: October 16, 2004
Date Started: November 2004
Date Completion: August 2017
Last Updated: February 14, 2017
Last Verified: February 2017