NCT00220922

Brief Summary

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_4 multiple-sclerosis

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_4 multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

September 20, 2005

Last Update Submit

April 7, 2011

Conditions

Multiple Sclerosis

Keywords

Copaxone

Outcome Measures

Primary Outcomes (1)

  • Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection

    four weeks of Period 1 and the four weeks of Period 2

Secondary Outcomes (1)

  • The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection

    four weeks of Period 1 and the four weeks of Period 2

Study Arms (2)

1

EXPERIMENTAL

injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Procedure: Alcohol Wipes vs. No Alcohol Wipes

2

EXPERIMENTAL

injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Procedure: Alcohol Wipes vs. No Alcohol Wipes

Interventions

Alcohol Wipes vs. No Alcohol WipesPROCEDURE
Also known as: Copaxone
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • years of age or older
  • Diagnosis of RRMS
  • Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

You may not qualify if:

  • Unable to perform subcutaneous self-injection
  • Pregnant, or trying to become pregnant, or breast feeding during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

EthanolGlatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • MerriKay Oleen-Burkey, Ph.D.

    Teva Neuroscience, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

August 1, 2004

Primary Completion

October 1, 2005

Study Completion

February 1, 2006

Last Updated

April 8, 2011

Record last verified: 2011-04