Status:
TERMINATED
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Utrecht University
Conditions:
Chronic Neuropathic Pain
Eligibility:
All Genders
30-60 years
Phase:
PHASE4
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 patien...
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 effec...
Eligibility Criteria
Inclusion
- age, amitriptyline responder, adequately treated with amitriptyline in studied dose before study participation, pain intensity score (VAS) of at least 4 cm on a 10 cm scale, driving licence, driving experience, speak fluently Dutch, normal vision, right-handed
Exclusion
- psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00189059
Start Date
October 1 2002
End Date
May 1 2005
Last Update
September 16 2005
Active Locations (1)
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1
University of Utrecht
Utrecht, Utrecht, Netherlands, 3508 TB