Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 673-682 , November 2009

The INFUSE-Morphine IIB Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneous Morphine in Healthy Volunteers

  • Jay R. Thomas, MD, PhD

      Affiliations

    • Department of Supportive Care Medicine, City of Hope, Duarte, California, USA
    • Corresponding Author InformationAddress correspondence to: Jay R. Thomas, MD, PhD, City of Hope, 1500 East Duarte Road, Machris 1111, Duarte, CA 91010-3000, USA.
    • ,
  • Richard C. Yocum, MD

      Affiliations

    • Department of Drug Development and Medical Affairs, Rockwell Medical Technologies, Inc., Wixom, Michigan, USA
    • ,
  • Michael F. Haller, PhD

      Affiliations

    • Department of Research and Development, Halozyme Therapeutics, Inc., San Diego, California, USA
    • ,
  • Jocelyne Flament, MD

      Affiliations

    • European Organisation for Research and Treatment of Cancer AISBL-IVZW, Brussels, Belgium

,Accepted 1 April 2009.

  • Image Result

    Study design: six treatment sequences for administration of 2mg morphine.

    Study design: six treatment sequences for administration of 2mg morphine.

  • Image Result

    a) Pharmacokinetic curves for plasma morphine concentration over sixhours postinjection and b) detailed view over the first 60minutes postinjection for each administration method. LLOQ, lower limit of

    a) Pharmacokinetic curves for plasma morphine concentration over sixhours postinjection and b) detailed view over the first 60minutes postinjection for each administration method. LLOQ, lower limit of quantification.

  • Image Result
    Pharmacokinetic curves for M6G plasma concentration over the first sixhours postinjection for each administration method. LLOQ, lower limit of quantification.

    Pharmacokinetic curves for M6G plasma concentration over the first sixhours postinjection for each administration method. LLOQ, lower limit of quantification.

  • Image Result
    Mean subjective discomfort at injection site at baseline and fiveminutes. 0 = no discomfort, 100 = worst possible discomfort (100 mm VAS scale).

    Mean subjective discomfort at injection site at baseline and fiveminutes. 0 = no discomfort, 100 = worst possible discomfort (100 mm VAS scale).

  • Image Result
    a) Edema and b) rash assessments.

    a) Edema and b) rash assessments.

 Halozyme Therapeutics, Inc. funded the study. Baxter Healthcare Corporation supported the study with study documents, database, and statistical analysis. Editorial assistance in the preparation of this manuscript was provided by Barbara J. Goldman, RPh, of Advogent, and funded by Baxter.

 When the study was conducted, Dr. Flament was employed by Baxter Healthcare Corporation, Deerfield, IL, and Dr. Yocum was employed by Halozyme Therapeutics, Inc. San Diego, CA.

 Clinical Trial Registration: www.ClinicalTrials.gov, Identifier: NCT 00311519.

PII: S0885-3924(09)00728-3

doi: 10.1016/j.jpainsymman.2009.03.010

Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 673-682 , November 2009

Article Tools

* Image Usage & Resolution