drugset / Trial / NCT00047580

Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

NCT00047580

Phase 3 Completed 120 enrolled Elan Pharmaceuticals
RandomizedOpen-labelTreatment

Summary

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

Timeline

Start
2002-06
Primary completion
Completion
2002-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Tizanidine Small molecule