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Arimidex in McCune Albright Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00055302
Recruitment Status : Completed
First Posted : February 26, 2003
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 25, 2003
First Posted Date  ICMJE February 26, 2003
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE August 2002
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00055302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arimidex in McCune Albright Syndrome
Official Title  ICMJE An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE McCune-Albright Syndrome
Intervention  ICMJE Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Arimidex 1 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2014)
40
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
30
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   United Kingdom
Removed Location Countries Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT00055302
Other Study ID Numbers  ICMJE 1033IL/0046
D5394C00046
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date August 2015

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