Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189072
Status:
TERMINATED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Effects of Gabapentin in the Treatment of Neuropathic 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 Gabapentin 900-3600 Mg on Driving Ability Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
Status:
TERMINATED
Status Verified Date:
2005-05
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 aim of this study was to explore the effects of pain on the one hand and the effects of treatment of pain with gabapentin 900 1200 1800 or 2400 mg on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration
Detailed Description:
Numerous studies demonstrate neuropsychological impairment in patients with chronic pain particularely on measures assessing attentional capacity processing speed and psychomotor speed About 50 of the patients suffering from neuropathic pain are treated with anticonvulsants as a treatment against serious pain complaints and experience good pain relief Gabapentin is one of the most prescribed anticonvulsants for the treatment of neuropathic pain An important disadvantage of treatment with gabapentin could be the occurrence of side effects such as somnolence and fatigue These side effects can constitute a crucial problem for patients treated with gabapentin who must operate a motor vehicle or other dangerous machinery However pain affects cognition negatively and possibly also driving Therefore another possibility is that treatment with gabapentin for these pain complaints can improve driving because the pain has less influence Since driving is an activity of daily living that is important in maintaining independency in the community such as access to employment and social activities it is important to establish the effects of using gabapentin on these abilities No studies have been conducted so far to investigate driving abilities of patients with neuropathic pain treated with gabapentinThe aim of this study was to explore the effects of pain on the one hand and the effects of acute Day 1 and subchronic Day 15 treatment of pain with gabapentin 900 1200 1800 or 2400 mg on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration This study is a two-period double-blind placebo-controlled cross-over randomised study
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