Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189059
Status:
TERMINATED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
Status:
TERMINATED
Status Verified Date:
2005-04
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 acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patientsIt was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute but not after subchronic treatment
Detailed Description:
The present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline compared to placebo after single Day 1 acute effects and repeated Day 15 subchronic effects administration on driving performance in neuropathic pain patients In addition to the on-the-road driving test laboratory tests measuring driving-related skills were administered Moreover effects of amitriptlyine on an attentional capacity task were tested using Event-Related Potentials ERPs It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute but not after subchronic treatment
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