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The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections

This study has been withdrawn prior to enrollment.
(Not approved by IRB)
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00988988
First received: September 30, 2009
Last updated: August 2, 2011
Last verified: August 2011
History of Changes

September 30, 2009
August 2, 2011
February 2010
November 2010   (final data collection date for primary outcome measure)
To determine if the use of ethyl-α-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by wheal, flare and itch response following subcutaneous injection of glatiramer acetate for the treatment of Multiple Sclerosis [ Time Frame: Three weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00988988 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate

Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site.

The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: AGEE cream
    AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled. It will be used immediately after injection and repeated as needed.
  • Drug: 1% Steroid Cream
    comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.
  • Drug: topical placebo cream with no active ingredients
    Cream to be applied immediately after injection and repeated as needed.
  • Active Comparator: Steroid Cream
    1% steroid cream
    Intervention: Drug: 1% Steroid Cream
  • Active Comparator: AGEE cream
    AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled
    Intervention: Drug: AGEE cream
  • Active Comparator: placebo
    inactive cream
    Intervention: Drug: topical placebo cream with no active ingredients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to give informed consent
  • Between ages 19-65
  • Laboratory supported diagnosis of multiple sclerosis
  • Currently treated with injectable GA, experiencing wheal and flare after injection

Exclusion Criteria:

  • Unable to give informed consent
  • Treated with any other therapy for Multiple Sclerosis
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00988988
399-09-FB
No
Mary Filipi, Ph.D., APRN Assistant Professor, University of Nebraska Medical Center
University of Nebraska
Teva Pharmaceutical Industries
Principal Investigator: Mary Filipi, PhD, APRN University of Nebraska
University of Nebraska
August 2011

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