A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Procedure: Warm compress prior to injection of glatiramer acetate; Drug: glatiramer acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239993

PM016

Details and patient eligibility

About

This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female, 18 years or older, with a diagnosis of RRMS
2. Willing and able to complete all procedures and evaluations related to the study.
3. Willing to provide Informed Consent

Exclusion criteria

1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation which the investigator or nurse feels may interfere with participation in the study.
4. Pregnant, or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

skin reactions with the use of warm compress prior to performing a Copaxone® injection

Treatment:

Drug: glatiramer acetate

2

Experimental group

Description:

skin reactions without the use of warm compress prior to performing a Copaxone® injection

Treatment:

Procedure: Warm compress prior to injection of glatiramer acetate