Arimidex in McCune Albright Syndrome - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00055302

Purpose

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.

Condition	Intervention	Phase
McCune-Albright Syndrome	Drug: Arimidex 1 mg	Phase II

Genetics Home Reference related topics: Melnick-Needles syndrome

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

Further study details as provided by AstraZeneca:

Estimated Enrollment:

30

Eligibility

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055302

Locations

United States, California
Research Site
Sacramento, California, United States
United States, Florida
Research Site
Tallahassee, Florida, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
France
Research Site
Montpellier, France
Research Site
Paris, France
Germany
Research Site
Osnabrueck, Germany
Research Site
Erlangen, Germany
Research Site
Berlin, Germany
Italy
Research Site
Torino, Italy
Spain
Research Site
Madrid, Spain
Research Site
Barcelona, Spain
United Kingdom
Research Site
Manchester, United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Arimidex Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	1033IL/0046
Study First Received:	February 25, 2003
Last Updated:	May 3, 2006
ClinicalTrials.gov Identifier:	NCT00055302
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

vaginal bleeding
advanced bone age
fibrous dysplasia
MAS
McCune-Albright Syndrome

Study placed in the following topic categories:

Anastrozole
Fibrous dysplasia of bone
Puberty, Precocious
Fibrous Dysplasia of Bone
Osteochondrodysplasias
Precocious puberty
Hemorrhage

Fibrous Dysplasia, Polyostotic
Bone Diseases
Fibrous dysplasia
Musculoskeletal Diseases
Bone Diseases, Developmental
McCune Albright syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Syndrome
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009