A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects

Summary

The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer's is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.

Timeline

Start

2005-11

Primary completion

—

Completion

2006-01

Outcome

Met primary endpoint

paper After SC dosing, morphine mean T(max) was significantly shorter with rHuPH20 than without it. PMID 19819667 ↗

Publications

• Thomas JR, Yocum RC, Haller MF, Flament J. The INFUSE-Morphine IIB study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneous morphine in healthy volunteers. J Pain Symptom Manage. 2009 Nov;38(5):673-82. doi: 10.1016/j.jpainsymman.2009.03.010. Epub 2009 Oct 12.

Drugs

Indications

No indication recorded.