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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®.

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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

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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