Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047580
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2002-10-08
Brief Title:
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
Sponsor:
Elan Pharmaceuticals
Organization:
Elan Pharmaceuticals
Study Overview
Official Title:
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
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None