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

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240032
• Other study ID #: PM014
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: April 7, 2011
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• glatiramer acetate injection with oral cetirizine hydrochloride
Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
• glatiramer acetate with placebo
Copaxone® injection 20 mg, oral placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection Site Reaction	Injection site reaction after taking antihistamine	5 weeks	No

External Links

•   For more information about Multiple Sclerosis
•   For more information about Teva Neuroscience, Inc.