Clinical Trial Results:
Treatment of acute locomotoric pain in the geriatric patient: comparison of effectiveness and safety between step 2 (weak opioids) and step 3 (strong opioids) pain relief of the WHO-ladder.
Summary
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EudraCT number |
2016-002379-89 |
Trial protocol |
BE |
Global end of trial date |
06 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Aug 2024
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First version publication date |
08 Aug 2024
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Other versions |
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Summary report(s) |
manuscript full data set Final Study Report |
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 |
AGO/2016/007
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Heymanslaan 10, Gent, Belgium, 9000
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Public contact |
Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
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Scientific contact |
Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
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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 |
06 Jul 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Sep 2020
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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 investigate whether there is a difference in effectiveness and safety between two commonly used therapeutic strategies: step 2 versus step 3 of the WHO pain ladder.
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Protection of trial subjects |
treatment was based upon good clinical practice
adverse events were monitored and therapy was stopped if necessary
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Sep 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 |
Belgium: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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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) |
0
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From 65 to 84 years |
25
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85 years and over |
24
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Recruitment
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Recruitment details |
See attachment Final Study Report | |||||||||
Pre-assignment
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Screening details |
70 years or older, admitted to the acute geriatric ward and suffering from acute (less than 72 hours) moderate to severe (numeric rating scale (NRS) ≥ 5) locomotor pain on at least one moment on the day of inclusion | |||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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oxycodone group | |||||||||
Arm description |
patients treated with strong opioids | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
oxycodone
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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 |
oxycodone extended release (ER) 5mg twice a day, with oxycodone instant release (IR) 5mg as rescue medication in case of breakthrough pain, with a maximum of six times a day
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Arm title
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tramadol group | |||||||||
Arm description |
patients treated with weak opioids | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
tramadol
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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 |
tramadol extended release (ER) 50mg twice a day, with tramadol instant release (IR) 50mg as rescue medication in case of breakthrough pain, with a maximum of four times a day
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End points reporting groups
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Reporting group title |
oxycodone group
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Reporting group description |
patients treated with strong opioids | ||
Reporting group title |
tramadol group
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Reporting group description |
patients treated with weak opioids |
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End point title |
effect on pain | ||||||||||||
End point description |
effect on pain, measured by NRS
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End point type |
Primary
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End point timeframe |
7 days
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Statistical analysis title |
effect on pain | ||||||||||||
Comparison groups |
oxycodone group v tramadol group
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
daily
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
naranjo | ||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
tramadol group
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0.01% | |||||||||||||||
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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 |