February 14, 2011 | by Merck Serono S.A.
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February 14, 2011, Merck Serono, the pharmaceutical division of Merck KGaA, Darmstadt, Germany, today announced the enrollment of the first patients in ECOS, the Easypod Connect Observational Study. ECOS is the first longterm multi-national, observational study to assess the level of pediatric patients’ adherence to Saizen [somatropin (rDNA origin) for injection] therapy, Merck Serono’s human recombinant growth hormone, delivered via its electronic auto-injector easypodTM, which records injection data. Another objective of the study is to explore the potential impact of adherence on clinical outcomes in patients receiving Saizen via easypodTM.
ECOS aims at following at least 1000 pediatric patients, receiving Saizen therapy in approved indications and dosages, over a period of up to 5 years. During their patients’ medical visit, the investigators will monitor patients’ injections history with the easypodTM built-in dose memory, which will be downloaded to a data storage software and internet platform.
”To date, treatment adherence has only been reported subjectively by patients receiving growth hormone therapy. ECOS will objectively reveal the adherence level of patients. The study will allow clinicians to identify patients who adhere poorly to treatment, and consequently we hope to be able to optimize the management and the response of an individual patient in the long term" said Prof. Peter Davies, chairman of the ECOS Scientific Steering Committee at The University of Queensland, Australia. “Merck Serono’s goal is to help children reach their full height potential by offering innovative solutions. Investigators will be able to capitalize on the built-in injection history memory of easypodTM to accurately measure the level of adherence and its potential impact on patients’ growth outcomes while providing the medical community with country-specific data that may benefit the clinical management of growth hormone therapy”, said Fereydoun Firouz, Head of the Global Business Unit, Fertility and Endocrinology, at Merck Serono.
Patients aged between 2 and 18 years, without a fused growth plate, and treated by Saizen therapy using easypodTM are eligible to participate. An assessment of patient adherence will be performed on regular basis according to local practice. Yearly analyses of the data collected will be published over the 5 years of patient follow-up. ECOS study is not planned to be performed in the US.
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Source: Merck Serono S.A., Press release