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
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