Clinical Trial Results:
Effects of paracetamol on nociception in adolescents.
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Summary
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EudraCT number |
2011-005086-20 |
Trial protocol |
NL |
Global end of trial date |
13 Aug 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2022
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First version publication date |
01 Mar 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CHDR1117
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Centre for Human Drug Research
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Sponsor organisation address |
Zernikedreef 8, Leiden, Netherlands, 2333 CL
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Public contact |
L. Schrier, CHDR, 0031 715246400, lschrier@chdr.nl
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Scientific contact |
L. Schrier, CHDR, 0031 715246400, lschrier@chdr.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Aug 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Aug 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Aug 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
The proposed tests are without risks for the volunteer (e.g., do not cause tissue damage or psychological trauma).
As it is possible that in rare cases a participant might react to pain with a stress response or exaggerated pressor/baroreflex response (for example fainting), an exclusion criterion addressing risk factors for fainting have been included. In addition, participants will have unlimited access to fluids to ensure hydration prior and during the experiments to reduce the risk of fainting due to vasovagal stress responses. Also, participants will be given time to habituate to the laboratory setting before starting the tests. Therefore, the risk related to participating in this study is considered to be minimal.
The proposed tests generally cause some pain, but (1) the participant has control over the process (i.e. control of cessation during the test); (2) the pain mounts fairly slowly so that it can be terminated before it becomes severe, and (3) the discomfort subsides rapidly once the test is terminated. Also, the participant knows the maximum duration of the pain and that no harm is being done, despite the fact that the test is painful. When a volunteer displays resistance against any study related activity, the “Gedragscode verzet minderjarigen” (Code of conduct in case of resistance in minors) will be followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Start 28DEC2011 end 13AUG2014 in the Netherlands | |||||||||
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Pre-assignment
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Screening details |
Healthy male and female subjects aged 16 and 17 years, with consent from parents. Subjects indicating nociceptive tests intolerable at screening or achieving tolerance at >70% of maximum input intensity for any nociceptive test were also excluded. No alcohol or caffeine use 24 hours and no smoking 12 hours before and during studydays. | |||||||||
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Period 1
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Period 1 title |
Studyperiod (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Investigator, Monitor, Subject, Data analyst, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Paracetamol | |||||||||
Arm description |
Paracetamol 1000mg | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Paracetamol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Single dose 1000mg
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Arm title
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Placebo | |||||||||
Arm description |
Placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Single dose
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Baseline characteristics reporting groups
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Reporting group title |
Studyperiod
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Paracetamol
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Reporting group description |
Paracetamol 1000mg | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||
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End point title |
Tolerance levels for heat pain [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Period 1
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please refer to the uploaded PD report for the end points and analyses. |
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Attachments |
CHDR1117_PD_stats_output_2014-09-30 |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From first dose to follow up.
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Assessment type |
Systematic | ||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Studyperiod
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Reporting group description |
- | ||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
