invivodata Captures Symptom Relief Data in Endometriosis Trial
PITTSBURGH,September 25, 2008 /PRNewswire/ -- invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its DiaryPRO(R) field-based ePRO system was used to capture important secondary efficacy endpoint data in Neurocrine Biosciences' PETAL study, a Phase II clinical trial of its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.
Over 250 patients used invivodata's electronic diary twice daily to record the frequency and severity of endometriosis symptoms before, during, and after six months of treatment, using several different scales to measure dysmenorrhea and pelvic pain. Data captured on DiaryPRO helped Neurocrine demonstrate a clinically meaningful and statistically significant reduction in endometriosis pain from baseline among patients treated with elagolix.
"When conducting a clinical trial of this importance and magnitude, it's critical to choose a vendor that is knowledgeable about clinical development and easy to work with," said Chris O'Brien, MD, Chief Medical Officer at Neurocrine Biosciences. "invivodata's process for designing and implementing ePRO was comprehensive and straightforward, and easily fit within our clinical development timeline."
"The PETAL study represents an important step forward in Neurocrine's ongoing efforts to bring relief to patients suffering from endometriosis," said Doug Engfer, invivodata president and CEO. "We are thrilled to continue working with Neurocrine as they explore the full therapeutic potential of elagolix."
invivodata combines behavioral science, information technology, and clinical research expertise to capture high quality clinical trial data directly from patients. invivodata's electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata's solutions include comprehensive trial-support services that facilitate the collection of ePRO data, and web-based access to study data and operational reports that give researchers and sponsors visibility into study progress and improve trial efficiencies. invivodata's solution has been used in more than 200 trials and is the industry-leading ePRO system in delivering primary efficacy data for FDA drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, Calif., USA. For more information visit www.invivodata.com.
For more information, contact: invivodata inc. Christine Tobin Corporate Communications Specialist (412) 390-3000, ext. 3502 firstname.lastname@example.org
CONTACT: Christine Tobin, Corporate Communications Specialist, invivodatainc., +1-412-390-3000, ext. 3502, email@example.com
Ticker Symbol: (NASDAQ-NMS:NBIX)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: September 2008