Clinical Trial Results:
A double blind randomised parallel group trial of paracetamol versus placebo in conjunction with strong opioids for cancer related pain.
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Summary
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EudraCT number |
2016-000197-38 |
Trial protocol |
GB |
Global end of trial date |
31 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jul 2021
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First version publication date |
02 Jul 2021
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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 |
AC15006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02706769 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ACCORD (University of Edinburgh and NHS Lothian)
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Sponsor organisation address |
47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
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Public contact |
Professor Marie Fallon, University of Edinburgh, 0044 01316518600, marie.fallon@ed.ac.uk
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Scientific contact |
Professor Marie Fallon, University of Edinburgh, 0044 01316518600, marie.fallon@ed.ac.uk
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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 |
26 Jun 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Aug 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Aug 2018
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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 establish whether paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Jun 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United Kingdom: 28
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Worldwide total number of subjects |
28
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EEA total number of subjects |
28
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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) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
20
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85 years and over |
1
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
N/A | |||||||||
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Period 1
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Period 1 title |
Baseline (overall trial) (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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Paracetamol | |||||||||
Arm description |
Paracetamol 1 gram four times daily. | |||||||||
Arm type |
Active comparator | |||||||||
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, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Participants took paracetamol 1 gram (two capsules) four times daily (each dose at least 4 hours apart) for the 7 days of the intervention phase of the study. All capsules were consumed whole. Participants were issued with the medication on day 0 (day of randomisation) and asked to commence it the following day instead of their current usual paracetamol medication.
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
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, hard
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Routes of administration |
Other use
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Dosage and administration details |
Participants took placebo (two capsules) four times daily (each dose at least 4 hours apart) for the 7 days of the intervention phase of the study. All capsules were consumed whole. Participants were issued with the placebo on day 0 (day of randomisation) and asked to commence it the following day instead of their current usual paracetamol medication.
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End points reporting groups
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Reporting group title |
Paracetamol
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Reporting group description |
Paracetamol 1 gram four times daily. | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
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End point title |
Clinically relevant change in average pain score [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Between baseline (day 0) and end of study (day 8).
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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: A full statistical analysis plan is available. The proportion of participants showing a clinically relevant change in average pain score over treatment period was compared using a binomial test for the comparison of proportions, the difference in proportions was presented along with an accompanying 95% CI. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
All AEs and SAEs were recorded from the time a participant signed their consent form to take part in the study until completion of the study (day 8) or withdrawal from the study.
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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 |
21
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Study closed early - only 23 patients completed. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Oct 2017 |
Change to protocol to help increase recruitment:
1. Reduce the minimum average pain score from 4 to 2.
2. Reduce the time on the study drug from 2 weeks to 1 week.
3. Use a poster/leaflet to alert potentially eligible patients to the study (eg in relevant clinic waiting rooms).
4. Remove the inclusion criteria that participants should be under palliative care/oncology service review. This will enable recruitment via primary care, with support from the primary care network, who can send letters to potentially eligible patients at GP practices who volunteer to take part.
5. Omit the screening period for the group already on paracetamol, where they are able to reliably report stable pain for the last 3 days (in the opinion of the researcher).
6. Include a new post-trial assessment, to capture any changes in pain due to resumption of usual paracetamol or otherwise after the study.
7. Allow issuing of Participant Information Sheet and taking consent to occur on the same day.
8. Allow baseline assessments to be conducted by phone as well as in person.
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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 | |||
