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.

A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Elan Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Muscle Spasticity
• Spinal Cord Injury
• Stroke

Interventions

Type	Name	Description
DRUG	tizanidine hydrochloride capsule

Timeline

• Start date: 2002-06-01
• Completion: 2002-09-01
• First posted: 2002-10-10
• Last updated: 2015-12-14

Locations

16 sites across 1 country: United States