The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
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|ClinicalTrials.gov Identifier: NCT00988988|
Recruitment Status : Withdrawn (Not approved by IRB)
First Posted : October 2, 2009
Last Update Posted : August 3, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: AGEE cream Drug: 1% Steroid Cream Drug: topical placebo cream with no active ingredients||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: Steroid Cream
1% steroid cream
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.
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
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.
Active Comparator: placebo
Drug: topical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988988
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-5330|
|Principal Investigator:||Mary Filipi, PhD, APRN||University of Nebraska|