Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 15, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00198458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Official Title ^ICMJE

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Brief Summary

The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cross-Sectional, Defined Population, Prospective Study

Condition ^ICMJE

Drug Hypersensitivity

Intervention ^ICMJE

Drug: Vitrase (ovine hyaluronidase); Sterile saline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Agreed to avoid disallowed meds

Exclusion Criteria:

Known hypersensitivity to hyaluronidase and/or bee sting
Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
Atopic individuals assessed by medical history
Topical/inhaled/systemic corticosteroids within 30 days
Concurrent use of antihistamines or anti-inflammatory during study
Active or chronic disease likely to affect immune function
History of alcohol/drug abuse within 6 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00198458

Responsible Party

Study ID Numbers ^ICMJE

ISTA-VIT-CS05

Study Sponsor ^ICMJE

ISTA Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

Information Provided By

ISTA Pharmaceuticals

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP