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

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: glatiramer acetate with placebo; Drug: glatiramer acetate injection with oral cetirizine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240032

PM014

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Copaxone® with Zyrtec

Active Comparator group

Treatment:

Drug: glatiramer acetate injection with oral cetirizine hydrochloride

Copaxone® with placebo

Experimental group

Treatment:

Drug: glatiramer acetate with placebo