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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00027391 |
This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.
Condition | Intervention |
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Muscular Dystrophies |
Drug: Albuterol Drug: Oxandrolone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Official Title: | Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy |
Estimated Enrollment: | 160 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | August 2004 |
Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | FD-R-2029-01, FD-R-002029-01 |
Study First Received: | December 5, 2001 |
Last Updated: | January 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00027391 |
Health Authority: | United States: Food and Drug Administration |
Muscle Weakness, Muscular Dystrophy |
Muscular Dystrophies Muscular Diseases Genetic Diseases, Inborn Neuromuscular Diseases Musculoskeletal Diseases Muscular Disorders, Atrophic |
Asthenia Albuterol Atrophy Muscular dystrophy Muscle Weakness Oxandrolone |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Reproductive Control Agents |
Hormones Pharmacologic Actions Adrenergic Agonists Anabolic Agents Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Androgens |