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An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection (Song)
The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.
Details
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 147 |
| Start date | 2009-07 |
| Completion | 2009-11 |
Conditions
- Relapsing Remitting Multiple Sclerosis
Interventions
- Glatiramer Acetate
- Experimental Glatiramer Acetate
Primary outcomes
- Subject-reported Pain Associated Immediately After Each Injection — 5 weeks of injections
A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.