Arimidex in McCune Albright Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00055302
First received: February 25, 2003
Last updated: January 3, 2013
Last verified: January 2013
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial male-limited precocious puberty
McCune-Albright syndrome
mucopolysaccharidosis type IV
Drug Information available for:
Anastrozole
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth
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, 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 | |
| Berlin, Germany | |
| Research Site | |
| Erlangen, Germany | |
| Research Site | |
| Osnabrueck, Germany | |
| Italy | |
| Research Site | |
| Torino, Italy | |
| United Kingdom | |
| Research Site | |
| London, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Arimidex Medical Science Director, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00055302 History of Changes |
| Other Study ID Numbers: | 1033IL/0046, D5394C00046 |
| Study First Received: | February 25, 2003 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
vaginal bleeding advanced bone age fibrous dysplasia MAS McCune-Albright Syndrome |
Additional relevant MeSH terms:
|
Fibrous Dysplasia, Polyostotic Fibrous Dysplasia of Bone Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Anastrozole |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013