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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®.

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: glatiramer acetate injection with oral cetirizine hydrochloride (Drug); glatiramer acetate with placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
MerriKay Oleen-Burkey, Ph.D., Study Director, Affiliation: Teva Neuroscience, Inc.

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.

Clinical Details

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

Primary outcome: Injection Site Reaction

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

For more information about Teva Neuroscience, Inc.

Starting date: October 2004
Last updated: April 7, 2011

Page last updated: August 23, 2015

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