NCT00311519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

April 6, 2006

Status Verified

April 1, 2006

First QC Date

April 4, 2006

Last Update Submit

April 5, 2006

Conditions

Healthy

Keywords

Subcutaneous hydrationHylenexHyaluronidase

Outcome Measures

Primary Outcomes (1)

  • Average infusion flow rate (mL/hr) derived from the time to infuse 400 mL of lactated ringers

Secondary Outcomes (11)

  • Average SC infusion rate of flow (mL/hr) derived from time required to drain 400 mL from the 500 mL infusate bag, fluid and tubing AND for the arm circumference to return to baseline

  • Flow rate determined by weight of infusate bag, fluid and tubing at specified timepoints

  • For SC infusions, change in arm circumference in three locations in the vicinity of the site of infusion

  • For SC infusions, time from the beginning of infusion until arm circumference returns to baseline

  • Subject assessment of local discomfort by placing a mark on a 0 100 mm visual analogue scale (VAS) anchored by no discomfort and worst possible discomfort

  • +6 more secondary outcomes

Interventions

HylenexDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females aged 18 to 60 years, inclusive
  • Agreement that there will be no fluid intake for 12 hours prior to the start of the study infusion (except sips of water to take necessary medications)
  • Vital signs (BP, HR, RR) within normal range
  • Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of infusion
  • Adequate venous access in at least one forearm
  • A negative pregnancy test (if female of child-bearing potential) within 7 days of infusion
  • Decision-making capacity
  • Signed, written IRB-approved informed consent

You may not qualify if:

  • Extremity edema
  • Upper extremity pathology that could interfere with study outcome (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.)
  • History of cardiovascular disease
  • Rales on lung auscultation
  • Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX
  • Known allergy to bee or vespid venom
  • Known coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials

Long Beach, California, 90806-2325, United States

Location

Related Publications (1)

  • 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.

    PMID: 19819667DERIVED

Study Officials

  • Javier T Quesada, OD

    West Coast Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

November 1, 2005

Study Completion

January 1, 2006

Last Updated

April 6, 2006

Record last verified: 2006-04

Locations

US(1)