| Study: | Open-label, Phase III study comparing pain relief provided by study medication versus IVPCA morphine during the first 24-72 hours following either hip-replacement or abdominal/pelvic surgery. Over 11 months, hip-surgery trials were conducted at 55 US sites enrolling 800 subjects; and abdominal-surgery trials were conducted at 45 US sites enrolling 500 subjects. |
| Challenges: | Midway through the studies, a key concomitant medication was withdrawn from the market. |
| Solutions: | The PharmaNet Neuroscience team worked closely with the sponsor and investigators to amend the protocol to account for the concomitant medication that was no longer available. The study was restarted as quickly as possible. |
| Outcome: | Enrollment completed on scheduled despite the concomitant medication issue and a short study stoppage. Both studies were successful, helped support the sponsor’s NDA submission, and ultimately led to the medication’s approval. |
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In Phase II-IV PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors. |
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Post-Operative Pain
PharmaNet Development Group, Inc.
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
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