- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055302
Arimidex in McCune Albright Syndrome
August 31, 2015 updated by: AstraZeneca
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France
- Research Site
-
Paris, France
- Research Site
-
-
-
-
-
Berlin, Germany
- Research Site
-
Erlangen, Germany
- Research Site
-
Osnabrück, Germany
- Research Site
-
-
-
-
-
Torino, Italy
- Research Site
-
-
-
-
-
London, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Arimidex (anastrozole) 1mg once daily by mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
February 25, 2003
First Submitted That Met QC Criteria
February 25, 2003
First Posted (Estimate)
February 26, 2003
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 31, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Fibrous Dysplasia of Bone
- Syndrome
- Fibrous Dysplasia, Polyostotic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
Other Study ID Numbers
- 1033IL/0046
- D5394C00046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on McCune-Albright Syndrome
-
Tovah BursteinRecruitingFibrous Dysplasia | McCune Albright Syndrome | Mazabraud SyndromeUnited States
-
Hospices Civils de LyonCompletedFibrous Dysplasia of Bone | McCune Albright SyndromeFrance
-
Natasha Appelman-DijkstraRecruitingFibrous Dysplasia | McCune Albright SyndromeNetherlands
-
Boston Children's HospitalNational Institutes of Health (NIH)Enrolling by invitation
-
National Institute of Dental and Craniofacial Research...CompletedPrecocious Puberty | McCune Albright Syndrome | Polyostotic Fibrous DysplasiaUnited States
-
National Institute of Dental and Craniofacial Research...CompletedMcCune Albright Syndrome | Polyostotic Fibrous DysplasiaUnited States
-
Children's Mercy Hospital Kansas CityKBRCompleted
-
National Institute of Dental and Craniofacial Research...RecruitingMcCune-Albright SyndromeUnited States
-
National Institute of Dental and Craniofacial Research...CompletedPolyostotic Fibrous DysplasiaUnited States
-
National Institute of Mental Health (NIMH)CompletedPET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright SyndromeNervous System DiseaseUnited States
Clinical Trials on Arimidex 1 mg
-
Aevi Genomic Medicine, LLC, a Cerecor companyCompletedAttention Deficit Disorder With HyperactivityUnited States
-
PfizerCompleted
-
Johnson & Johnson K.K. Medical CompanyCompleted
-
GlaxoSmithKlineCompleted
-
Bio Sidus SACompleted
-
Merck Sharp & Dohme LLCTerminatedAlzheimer's Disease | Amnestic Mild Cognitive Impairment | Prodromal Alzheimer's Disease
-
Galderma R&DCompletedHealthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected SkinFrance
-
Zydus Therapeutics Inc.RecruitingPrimary Biliary CholangitisUnited States, Argentina, Iceland, Turkey
-
Ain Shams UniversityCompletedHematologic Pregnancy ComplicationsEgypt
-
SunovionCompletedPediatric Attention Deficit Hyperactivity DisorderUnited States