E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients suffering from chronic non-cancer pain responsive to opioid analgesics under already existing long-term treatment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067033 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013496 |
E.1.2 | Term | Disturbance in attention |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10027375 |
E.1.2 | Term | Mental impairment (excl dementia and memory loss) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
Correlation between performance in driving test and computerized test of driving related skills |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 <=1. 6) Expected inability to drive the experimental car or to complete computerized testing or endangerment of being overstrained during the driving test or during computerized testing according to the estimation of the physician accomplishing the medical check up. 7) Psychological or psychiatric disorders or severe physical disorders (history or current evidence of severe physical or mental disorders, serious gastrointestinal, hepatic, renal, cardiovascular or neurological disorders or severe allergies) that may interfere with participation in computerized testing or driving test 8) Subjects with alcohol or drug abuse or dependency 9) Unwillingness or inability to abstain from consumption of alcohol, psychoactive medication or drugs within 24 hours prior to the assessment day (urine drug screening, alcohol breath analyzer) 10) Excessive smokers (more than 20 cigarettes a day) or excessive drinkers (more than 28 glasses of alcohol containing beverages per week) 11) Regular intake of Benzodiazepines (≥ 4 times per week) 12) Intake of Benzodiazepines within 2 days before assessment days 13) Regular intake of barbiturates (> 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®) |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Impairment in driving ability caused by side effects |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
mixed within-between design |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
A matched group of healthy subjects |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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All subjects have completed all parts of the driving test and the computerized test of driving related skills |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |