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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.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00240032
First received: October 13, 2005
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240032

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

Additional Information:
No publications provided

Responsible Party: Thomas Smith, MD, VP Medical Affairs, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00240032     History of Changes
Other Study ID Numbers: PM014
Study First Received: October 13, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Cetirizine
Copolymer 1
Histamine Antagonists
Histamine H1 Antagonists
Adjuvants, Immunologic
Anti-Allergic Agents
Histamine Agents
Histamine H1 Antagonists, Non-Sedating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014