CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 147 enrolled
Drug / intervention
Glatiramer Acetate +1 moredrug
Likely dose
Experimental Glatiramer Acetate 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00947752
NCT00947752Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jul 28, 2009·Updated Mar 14, 2017

In Brief

A Phase 3 clinical trial evaluating Glatiramer Acetate and Experimental Glatiramer Acetate for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 147 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.9 years ago

Interventions

Glatiramer Acetatedrug

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.

Experimental Glatiramer Acetatedrug

GA 20 mg/0.5 mL