Optimer's clinical trials are a fundamental step in the development of innovative hospital specialty medicines that have a positive impact on society and provide value to the healthcare system. We place a high priority on communicating information and results regarding our ongoing and completed clinical trials. We have registered, and will continue to register, all of our Phase 2, Phase 3 and Phase 4 company-sponsored clinical trials on the National Institutes of Health website www.clinicaltrials.gov.
Optimer® takes seriously our responsibility to deliver the highest standard of ethical practice when conducting clinical studies. We comply with all relevant laws and regulations of the country or countries in which our trials are being conducted, and we have our own policies and standards, which are in line with international codes such as Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices and ICH1. When conducting a trial anywhere in the world, we operate to the highest of the standards required by the external international, regional or local regulations, and our own internal standards.
Optimer supports the dissemination of scientific data in an ethical and scientifically responsible manner. We comply with good publication practices (GPPs) in the planning, development and management of our scientific communications, including publications and presentations at scientific meetings. Optimer is committed to timely and non-biased publications that follow the uniform requirements established by the International Committee of Medical Journal Editors (ICMJE), including the ICMJE authorship requirements.
We are currently recruiting patients for two clinical trials:
Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation.
Phase 2a Study testing the safety, tolerability and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea.