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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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