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Clinical Studies and Trials

Unit of Clinical Studies and Trials

Through this unit we promote the participation of faculty of the UPR School of Medicine in clinical trials.  By means of the development of an interdisciplinary environment, including alliances with the industry and the community, we facilitated the integration of resources and development of strategies to increase the participation on research endeavors of volunteers, sponsors, investigators, and the research personnel.
Clinical Trials

Title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults with an Acute Exacerbation of Asthma.

A phase II clinical study was initiated by the office in collaboration with the Director of the Department of Emergency Medicine, Dr. Juan González, as Principal Investigator and with the sponsorship of the pharmaceutics MediciNova Inc. The main purpose is to evaluate the safety and efficacy of a new drug when administered intravenously as an adjunct to standard therapy to adults with an acute exacerbation of asthma. The study was approved by the UPR Medical Sciences Campus’ IRB and the Western IRB, and we will begin the recruitment of the patients in the next several months. This study will help us to better understand asthma disparities and medication resistance among Hispanics.

Title: Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America (see Research in the Office for Clinical Research).

Phase II clinical study was realized, heading by Dr. Zevallos, and the Director of the OCCHR, Dr. Enid J. García, in collaboration with the Director of the Department of Emergency Medicine, Dr. Juan A. Gonzalez, as Co-Investigator. This study was sponsored by the pharmaceutics Sanofi-Pasteur. The main purpose is to describe the humoral immune response to each dengue serotype before and after each vaccination with Sanofi Pasteur's CYD dengue vaccine, and to evaluate the safety of each vaccination with Sanofi Pasteur's CYD dengue vaccine. It was approved by Medical Sciences Campus’ IRB in May 2009. The study was conducted at University of Puerto Rico’s Hospital at Carolina and finish on March 2011.