E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers - pain |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
E.1.2 | System Organ Class | 100000004867 |
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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 |
The main objectives are to investigate the effect of tapentadol on the central, the autonomic and the enteric nervous systems. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to show that tapentadol has less effect on the autonomic and enteric nervous system in comparison with oxycodone. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed informed consent before any study specific procedures • Able to read and understand Danish. • The researcher believes that the participant understands what the study entails, are capable of following instructions, are able to attend when needed, are expected to complete the study • Male • Between 20 and 45 years of age • Scandinavian descent • Healthy • Opioid naïve subjects (who have not taken opioid doses for 1 week or longer)
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E.4 | Principal exclusion criteria |
• • Female • Known allergy towards pharmaceutical compounds similar to those used in the study • Participation in other studies within 14 days of first visit • Expected need of medical/surgical treatment during the course of the study • History of psychiatric illness • History of persistent or recurring pain conditions • Nicotine consumption • Daily alcohol consumption • History of substance abuse • Family history of substance abuse • Use of any analgesic medication within 48 hours before start as well as for the duration of the study period • Use of any medication (herbal as well as any over-the-counter drugs) within 48 hours before start of the study period • Intake of alcohol within 24 hours before start of the study period • Use of prescription medicine and/or herbal medicine • Need to drive motor vehicle within the treatment periods • Severe respiratory depression • Increased intracranial pressure • Paralytic ileus • Severe decreased renal or hepatic function • Treatment with MAO-inhibitors • Cor pulmonale • Severe COPD or acute severe asthma
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points will be to evaluate potential changes in pain sensitivity (as measured from the withdrawal reflex, spinal EPs, etc.) towards electrical, mechanical and thermal stimulation and to assess the effect on the autonomic (measured from brainstem parasympathetic efferent activity, known as cardiac vagal tone) and enteric (measured by assassing the gut transit time and MR colonography) nervous systems. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 14 days of treatment. Gut transit is evaluated after 4 days of treatment. |
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E.5.2 | Secondary end point(s) |
To evaluate changes in subjective pain experience (as measured by numerical rating scales) towards nociceptive stimulation between placebo and active medications.
To evaluate changes in subjective experience of the effect on the enteric nervous system (measured by questionnaires) between placebo and active medications. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 14 days of treatment.
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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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Complete data collection from 21 healthy volunteers |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |