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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®.

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: October 13, 2005
Last updated: April 7, 2011
Last verified: April 2011
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 Intervention Phase
Multiple Sclerosis Drug: glatiramer acetate injection with oral cetirizine hydrochloride Drug: glatiramer acetate with placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

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

Enrollment: 80
Study Start Date: October 2004
Study Completion Date: July 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®


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

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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Please refer to this study by its identifier: NCT00240032

Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
  More Information

Additional Information:
Responsible Party: Thomas Smith, MD, VP Medical Affairs, Teva Neuroscience Identifier: NCT00240032     History of Changes
Other Study ID Numbers: PM014
Study First Received: October 13, 2005
Last Updated: April 7, 2011

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Glatiramer Acetate
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents processed this record on September 21, 2017