patients suffering from chronic non-cancer pain responsive to opioid analgesics under already existing long-term treatment MedDRA version: 11.0 Level: LLT Classification code 10067033 Term: MedDRA version: 9.1 Level: LLT Classification code 10013496 Term: Disturbance in attention MedDRA version: 9.1 Level: HLT Classification code 10027375 Term: Mental impairment (excl dementia and memory loss)
Conditions
Interventions
Trade Name: Durogesic Smat or generics
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: FENTANYL
CAS Number: 437387
Concentration unit: µg microgram(s)
Concentration type: not less then
Con
Sponsors
Federal Highway Research Institute / Bundesanstalt für Straßenwesen (BASt)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent. 2) Age: = 30 = 65: as far as possible three groups are built consisting of 10 persons each: 30-39, 40-49, 50-65. 3) Stable social background 4) Body weight within 16-30 according to body mass index (BMI) 5) Normal blood pressure and normal heart rate at rest 6) Vision normal or corrected to normal 7) Valid driver’s license for passenger cars 8) Kilometres travelled per year: at least 2.000 km per year during preceding 12 month 9) Driving on a regular basis: at least once per week 10) Ability to drive a passenger car with manual transmission 11) Chronic non-cancer pain responsive to opioid analgesics 12) Treatment for at least four weeks with • transdermal Fentanyl (e.g. Durogesic Smat®) or • transdermal Buprenorphine (e.g. Transtec®) or • retarded Oxycodone (e.g. Oxygesic®) 13) No dose change within the preceding 14 days 14) Dosage at least at • 12 µg/h transdermal Fentanyl • 35µg/h transdermal Buprenorphine • 2x5mg Oxycodone. 15) Co-medication with NSAID and/or anticonvulsants and/or antidepressants on a stable dose within the preceding 14 days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects who fail to meet any of the inclusion criteria 2) Persons who are imprisoned or are detained in a health mental institution by court or official order 3) Malignant disease 4) Severe disabilities that are expected to interfere with computerized testing or car driving 5) Women who are pregnant or breast feeding or women of child-bearing potential who are not using a highly effective contraception method with a pearl-index 3 times per week) as well as intake of barbiturates within 2 days before the assessment days 14) Daily intake of antidepressants in higher dosage (Amitryptilin > 75mg, Doxepin > 75mg, Imipramin > 75mg, Trazodon > 100mg, Sertralin > 50mg, Fluoxetin > 20mg, Fluvoxamin >75mg, Duloxetin > 120mg, Venlafaxin > 225mg, Citalopram > 10mg) 15) Daily intake of anticonvulsant in higher dosage (Carbamazepin > 1200mg, Oxcarbazepin >1800mg, Gabapentin >2400mg, Pregabalin >600mg) 16) Intake of MAO inhibitors 17) Regular intake of un-retarded opioids oder intake of un-retarded opioids within 2 days prior to assessment days 18) Regular intake of antihistamines 19) Inability to communicate meaningfully with the study staff (insufficient language skills) 20) Treatment with the combination of naloxone and Oxycodone (e.g. Targin®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess driving ability by a standardized on-the-road driving test and by a standardized computerized test of driving related skills of chronic pain patients under long term treatment with opioid analgesics. Performance of patients is compared to performance of matched healthy controls sober and alcoholized (BAC = 0.50 g/L);Secondary Objective: Correlation between performance in driving test and computerized test of driving related skills;Primary end point(s): Driving test: - Standard deviation of lateral position (SDLP;a measure of road tracking error, in practical terms, a composite index of allowed weaving, swerving and overcorrecting) - Time to Speed Adaptation while following a car which changes speed - Brake reaktion time Computerized test of driving related skills: An overall score is calculated by z-transformed values of all test scores of the computerized test battery | — |
Countries
Germany, Netherlands
Outcome results
None listed