Arimidex in McCune Albright Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00055302
First received: February 25, 2003
Last updated: October 2, 2014
Last verified: October 2014

February 25, 2003
October 2, 2014
August 2002
February 2006   (final data collection date for primary outcome measure)
The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Time Frame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00055302 on ClinicalTrials.gov Archive Site
Not Provided
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Arimidex in McCune Albright Syndrome
An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
McCune-Albright Syndrome
Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth
Experimental: 1
Intervention: Drug: Arimidex 1 mg
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
40
March 2015
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
  • females less than or equal to 10 years of age
  • diagnosed with McCune-Albright Syndrome
  • have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

  • any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
  • concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
  • liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
  • known hypersensitivity to any component of study medication
Female
up to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   United Kingdom
 
NCT00055302
1033IL/0046, D5394C00046
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
AstraZeneca
October 2014

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