“invivodata was able to deliver us the real-time data that we needed to develop an unbiased view into our patients’ pain experiences. This kind of data cannot be collected with paper diaries.”
Dr. Michael Gendreau
Chief Medical Officer, Cypress Bioscience
DiaryPRO Collects Primary Endpoint Data for Phase II Clinical Study in Diabetic Peripheral Neuropathy
- January 09, 2007
invivodata’s DiaryPRO Collects Primary Endpoint Data for Phase II Clinical Study in Diabetic Peripheral Neuropathy
invivodata's DiaryPRO solution used by patients to report daily pain frequency and severity
PITTSBURGH — Jan. 9, 2007 — invivodata® inc., the industry leader in electronic patient reported outcomes solutions for global clinical research, today announced that DiaryPRO®, its handheld electronic patient diary, was used to capture the primary endpoint data in a Phase II clinical study of Gabapentin GR™, an investigational extended-release tablet being developed by Depomed Inc. for the treatment of pain in patients with diabetic peripheral neuropathy (DPN), a nerve disorder caused by diabetes.
Nearly 150 patients with DPN recorded their assessments of pain frequency and severity on DiaryPRO every morning during a four-week period. Because DiaryPRO time- and date-stamped each entry, Depomed was able to confirm that the patients complied with the protocol and recorded their assessments at the appropriate times.
“invivodata’s expertise in designing and administering electronic diaries served an integral role in our ability to capture highly valuable and reliable data from our Phase II clinical trial of Gabapentin for individuals with DPN,” said Carl Pelzel, executive vice president and chief operating officer of Depomed. “We look forward to continuing to work with invivodata in our effort to reduce the development risk associated with bringing new therapeutic treatment options to market.”
“It’s exciting to leverage our experience in collecting valid and reliable PRO data to help Depomed determine the effectiveness of Gabapentin,” said Doug Engfer, president and CEO of invivodata. “We are thrilled to continue our relationship with Depomed as it explores the therapeutic potential of this novel compound in an effort to bring relief to the many people suffering from DPN today.”
About invivodata inc.
invivodata combines behavioral science, information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague self-report studies. The invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO for site-based PRO data collection, provides access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. invivodata’s solution has been used in more than 130 trials involving over 50,000 patients. It has also collected over 50 million patient-initiated records, and is the industry-leading eDiary 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 are in London, England; and its technology development center is in Scotts Valley, Calif., USA.
