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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240032
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: glatiramer acetate injection with oral cetirizine hydrochloride Drug: glatiramer acetate with placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.
Study Start Date : October 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2006

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Copaxone® with Zyrtec Drug: glatiramer acetate injection with oral cetirizine hydrochloride
Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
Other Name: Copaxone®, Zyrtec®
Experimental: Copaxone® with placebo Drug: glatiramer acetate with placebo
Copaxone® injection 20 mg, oral placebo
Other Name: Copaxone®


Outcome Measures
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Primary Outcome Measures :
  1. Injection Site Reaction [ Time Frame: 5 weeks ]
    Injection site reaction after taking antihistamine


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00240032


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
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Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
More Information
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Responsible Party: Thomas Smith, MD, VP Medical Affairs, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00240032    
Other Study ID Numbers: PM014
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cetirizine
Glatiramer Acetate
(T,G)-A-L
 Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents