A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

NCT ID: NCT00240032

Last Updated: 2011-04-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Copaxone® with Zyrtec

Group Type ACTIVE_COMPARATOR

glatiramer acetate injection with oral cetirizine hydrochloride

Intervention Type DRUG

Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet

Copaxone® with placebo

Group Type EXPERIMENTAL

glatiramer acetate with placebo

Intervention Type DRUG

Copaxone® injection 20 mg, oral placebo

Interventions

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glatiramer acetate injection with oral cetirizine hydrochloride

Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet

Intervention Type DRUG

glatiramer acetate with placebo

Copaxone® injection 20 mg, oral placebo

Intervention Type DRUG

Other Intervention Names

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Copaxone®, Zyrtec® Copaxone®

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18 years of age or older
* Diagnosis of RRMS
* Beginning or recently (within \< 3months) began self-injecting Copaxone®

Exclusion Criteria

* Taking any other immunomodulatory therapy in conjunction with Copaxone®
* Unable to perform subcutaneous self-injection
* Pregnant or trying to become pregnant, or breast feeding during the study
* Previously participated in this study or in another clinical trial in the past 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Principal Investigators

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MerriKay Oleen-Burkey, Ph.D.

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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PM014

Identifier Type: -

Identifier Source: org_study_id

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