Abstract

The objectives of the double-blind study were to demonstrate the effect of oxandrolone on muscle strength and the progression of weakness in boys with Duchenne's muscular dystrophy during a 6 months treatment period, and to evaluate the safety and tolerability of the drug in this population. This open-label, active therapy extension protocol will allow those boys who received placebo therapy during the first six months of the study to now receive active drug (oxandrolone), with evaluation of its effects. Boys who had received active therapy during the first six months of study will continue receiving oxandrolone, providing evaluation of the longer-term efficacy and safety of this treatment.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000044-39
Application #
6303824
Study Section
Project Start
1999-12-01
Project End
2001-02-28
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of Rochester
Department
Type
DUNS #
208469486
City
Rochester
State
NY
Country
United States
Zip Code
14627

  Publications

Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Ternullo, Sharon R; Abdolahi, Amir; Williams, Geoffrey C (2017) Study of monotherapy versus combination therapy for tobacco dependence among heavily addicted smokers. J Am Pharm Assoc (2003) 57:77-81.e1
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Williams, Geoffrey C; Niemiec, Christopher P; Patrick, Heather et al. (2016) Outcomes of the Smoker's Health Project: a pragmatic comparative effectiveness trial of tobacco-dependence interventions based on self-determination theory. Health Educ Res 31:749-759
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Ettensohn, David B; Frampton, Mark W; Nichols, Joan E et al. (2016) Human Alveolar Macrophages May Not Be Susceptible to Direct Infection by a Human Influenza Virus. J Infect Dis 214:1658-1665
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Foglia, Elizabeth E; Nolen, Tracy L; DeMauro, Sara B et al. (2015) Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled. JAMA 313:2377-9
O'Connor, Thomas G; Wang, Hongyue; Moynihan, Jan A et al. (2015) Observed parent-child relationship quality predicts antibody response to vaccination in children. Brain Behav Immun 48:265-73

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