CHARLESTOWN, Mass.–(BUSINESS WIRE)–Nov. 17, 2004-
– Site acceptance, patient compliance, PHT study support already providing benefits early in study PHT Corporation, the leading provider of electronic patient reported outcome (ePRO) solutions used in over 130 trials worldwide, is pleased to announce that Orphan Medical has selected the LodPad(R) for its Phase II fibromyalgia trial. The study is being deployed across approximately 24 sites and 200 subjects throughout the United States and Canada.
First Patient In (FPI) occurred in June 2004, and Orphan Medical is very satisfied with the early results of the ePRO solution. Specifically, site acceptance and patient compliance are encouraging, and PHT's study support center has proven to be an effective service for Orphan as well. "We evaluated several vendors, and were assured by PHT's history of successful management and service that this would be replicated in pivotal trial for us," said Dr. Bill Houghton, Chief Scientific Officer at Orphan Medical. "The early results have justified our decision to date, as sites and subjects are responding well to the LogPad. Furthermore, PHT's study support center professionals have been highly efficient in responding to calls quickly and efficiently, enabling us to take full advantage of ePRO benefits right from the start of our trial."
The LogPad solution captures subject information relating to daily pain levels, daily fatigue symptoms and quality of sleep, as well as overall quality of life questions. "This is a very important trial for Orphan Medical, Inc., because it is the first clinical investigation outside of the narcolepsy indication," said Dr. Houghton. "Fibromyalgia is a condition that represents very significant unmet medical need, for there are no approved pharmacologic treatments, although there are several compounds under investigation at the present time.
Fibromyalgia represents a patient population that is much larger than the disease states we have studied to date, and therefore has great commercial significance to the Company. The data quality and the rigorous conduct of the clinical trial is of utmost importance to our assessment of the potential of Xyrem in this new indication." "We are pleased that Orphan is already realizing the valuable benefits it identified as critical success factors when selecting PHT as the eDiary vendor for this important trial," said Phil Lee, PHT President and CEO. "Orphan's work in central nervous system conditions is an example of an area of research that can greatly benefit from the advantages available with an eDiary and eSource system."
About Orphan Medical Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases treated by specialist physicians. Orphan Medical intends to build a strong presence in the sleep and central nervous system (CNS) markets. Orphan Medical's Internet Web site address is www.orphan.com.
About PHT Corporation PHT Corporation is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in over 130 trials worldwide. More than 50 biopharmaceutical and medical device companies, including 13 of the top 15 in the world, rely on PHT's innovative and comprehensive ePRO solutions for their Phase II, III and IV clinical studies. PHT's integrated Product Suite enables successful clinical trials by improving data quality, reducing data variance, and providing real-time access and analysis of the data collected. PHT leads the industry in experience with more than 70,000 subjects at 8,000 clinical sites in 45 countries and 34 languages around the globe. PHT, a pioneer in developing innovative technology to meet clinical research's evolving needs, is headquartered in Charlestown, MA, and Geneva, Switzerland. For more information, please visit www.phtcorp.com. LogPad and PHT are registered trademarks of PHT Corporation. (C) PHT Corporation