Trials / Completed
CompletedNCT00947752
Safety of New Formulation of Glatiramer Acetate
An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glatiramer Acetate | Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. |
| DRUG | Experimental Glatiramer Acetate | GA 20 mg/0.5 mL |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2009-09-01
- Completion
- 2009-11-01
- First posted
- 2009-07-28
- Last updated
- 2017-03-14
- Results posted
- 2011-06-09
Source: ClinicalTrials.gov record NCT00947752. Inclusion in this directory is not an endorsement.