E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nociceptive pain (disorders) |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
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 educate adolescents about clinical drug studies by involving them as project team members and participants in an experiment with negligible risk and minimal burden;
- To investigate the effects of paracetamol on nociception in adolescents;
- To describe saliva paracetamol concentrations in adolescents;
- To describe the PK/PD relationship of paracetamol in adolescents (using data obtained in the healthy adult volunteer study);
- To evaluate the applicability of the PainCart test battery in adolescents, including evaluation how adolescents have experienced trial participation.
|
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Agree to and be capable of signing an informed consent form.
Written informed consent from parents having parental responsibility or from the legal guardian;
Healthy male and female subjects;
Age: 16 or 17 years at screening;
Attending high school;
Body mass index between 18-30 kg∙m-2;
Able to refrain from strenuous physical exercise from 48 hours prior to nociceptive testing until dismissal from the CHDR clinic;
Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
Ability to communicate well with the investigator in the Dutch language.
Previous use of paracetamol without adverse effects
|
|
E.4 | Principal exclusion criteria |
Inability to comply with the requirements of the study;
Known liver and/or renal disease as determined by medical history taking;
Clinically significant findings as determined by medical history taking
Any current, clinically significant, known medical condition, in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud’s disease, urticaria, hypothyroidism) or pain (paraesthesia, etc.);
Medical history of fainting or syncope e.c.i.;
Previous allergic reaction to paracetamol;
Pregnancy and/or breast feeding in females;
Subjects indicating nociceptive tests intolerable at screening or achieving tolerance at >70% of maximum input intensity for any nociceptive test;
Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening;
Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic;
History or clinical evidence of alcoholism or drug abuse;
Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments;
Use of over-the-counter analgesic medications within 3 days of nociceptive assessments.
Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics: saliva paracetamol concentrations
Pharmacodynamics: pain threshold and tolerance levels for: heat pain (skin) (degrees Celsius), pressure pain (muscle) (kPa), electrical pain (skin) (mA), and cold pressor pain (sec).
Additionally, a short questionnaire will be taken after completion of the PainCart tests on the second occasion evaluating how participants have experienced participation.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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
|
Follow up visit of last subject undergoing trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |