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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240032

Enrollment

Registered

2005-10-17

Start date

2004-10-31

Completion date

2006-07-31

Last updated

2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief 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.

Interventions

DRUGglatiramer acetate injection with oral cetirizine hydrochloride

Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet

DRUGglatiramer acetate with placebo

Copaxone® injection 20 mg, oral placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Injection Site Reaction	5 weeks	Injection site reaction after taking antihistamine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026