The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
NCT ID: NCT00988988
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2010-02-28
2012-08-03
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Steroid Cream
1% steroid cream
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.
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
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.
placebo
inactive cream
topical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.
Interventions
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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.
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.
topical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between ages 19-65
* Laboratory supported diagnosis of multiple sclerosis
* Currently treated with injectable GA, experiencing wheal and flare after injection
Exclusion Criteria
* Treated with any other therapy for Multiple Sclerosis
19 Years
65 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Mary Filipi, PhD, APRN
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Other Identifiers
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0399-09-FB
Identifier Type: -
Identifier Source: org_study_id
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