A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
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ClinicalTrials.gov Identifier: NCT00240032 |
Recruitment Status :
Completed
First Posted : October 17, 2005
Last Update Posted : April 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: glatiramer acetate injection with oral cetirizine hydrochloride Drug: glatiramer acetate with placebo | Phase 4 |
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 |

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® |
- Injection Site Reaction [ Time Frame: 5 weeks ]Injection site reaction after taking antihistamine

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Study Director: | MerriKay Oleen-Burkey, Ph.D. | Teva Neuroscience, Inc. |
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 |
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 |