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Asperitol (PB0182): Preliminary Results of Clinical Trial. Kyle Evans Landon Pharmaceuticals Testing, Inc. LPT. Contents. Clinical Trial Client Company and Test Dates Medical Protocol Participant Demographics Medical Testing Results Summary and Recommendations. Clinical Trial.
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Asperitol (PB0182): Preliminary Results of Clinical Trial Kyle Evans Landon Pharmaceuticals Testing, Inc. LPT Landon Pharmaceuticals Testing
Contents • Clinical Trial • Client Company and Test Dates • Medical Protocol • Participant Demographics • Medical Testing • Results • Summary and Recommendations Landon Pharmaceuticals Testing
Clinical Trial • FDA Application Number 9284773-08 • Phase III Trial • Target disease: rheumatoid arthritis • Drug name: Asperitol • Drug code number PB0182 Landon Pharmaceuticals Testing
Client Company and Test Dates • Contact information • Barbara Shao, Ph.D. • Parmerleau Biotechnologies • 105 Patriot Way • Newton, MA 02459 • Phone 402-555-4366 • Trial start date: February 12, 2008 • Trial completion date: September 15, 2010 Landon Pharmaceuticals Testing
Medical Protocol • Standard double-blind protocol • Sites of clinical trials • New York City • Tampa, Florida • Lincoln, Nebraska • Sacramento, California • Pre-tested participants at clinics • Administered dosage: 20-mg pill • Bi-monthly medical tests of participants Landon Pharmaceuticals Testing
Participant Demographics Landon Pharmaceuticals Testing
Medical Testing • Joint fluid analysis • Blood tests • Radiographs (x-rays) • Patient-reported pain levels (10-point scale) Landon Pharmaceuticals Testing
Results Landon Pharmaceuticals Testing
Summary and Recommendation • Dramatic decrease of symptoms in females suggests that Asperitol could be a commercial success in treating rheumatoid arthritis among women • Moderate decrease of symptoms in males suggest that for some men, Asperitol could be effective • Parmerleau should apply to FDA for approval to do Phase IV clinical trial Landon Pharmaceuticals Testing