Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162786
Status:
TERMINATED
Last Update Posted:
2006-10-20
First Post:
2005-09-09
Brief Title:
Comparative Effects of Rupatadine 10 mg Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Sponsor:
J Uriach and Company
Organization:
J Uriach and Company
Study Overview
Official Title:
Comparative Effects of Rupatadine 10 mg Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Status:
TERMINATED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers performance on a standard over-the-road driving test and a car-following test
Detailed Description:
The study shall be conducted according to a three-way double-blind placebo and active controlled crossover design Treatment groups are identified as follows
Rupatadine
Hydroxyzine
Placebo
Rupatadine
Hydroxyzine
Placebo
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