Clinical Trial Results:
Pain management after operative treatment of extremity fractures, a randomized clinical trial
Summary
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EudraCT number |
2012-000680-24 |
Trial protocol |
NL |
Global end of trial date |
01 Oct 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2017
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First version publication date |
06 Jan 2017
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Other versions |
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 |
POSTrct_ORTGH
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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 |
Academisch Medisch Centrum
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Sponsor organisation address |
Meibergdreef 9, Amsterdam, Netherlands,
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Public contact |
P. Kloen, Academisch Medisch Centrum, +31 205663374, p.kloen@amc.uva.nl
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Scientific contact |
P. Kloen, Academisch Medisch Centrum, +31 205663374, p.kloen@amc.uva.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 |
11 Nov 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2015
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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 |
The primary objective of this study is to determine (differences in) patient satisfaction with pain relief and pain intensity (Numeric Rating Scale).
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Protection of trial subjects |
Escape medication could be provided
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2012
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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 |
Netherlands: 52
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Worldwide total number of subjects |
52
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EEA total number of subjects |
52
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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) |
45
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From 65 to 84 years |
6
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85 years and over |
1
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Recruitment
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Recruitment details |
Patients were recruited worldwide from July 2012 to March 2015 | ||||||||||||||||||
Pre-assignment
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Screening details |
Patients were screened after extremity fractures occured | ||||||||||||||||||
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 |
Single blind [1] | ||||||||||||||||||
Roles blinded |
Investigator, Monitor, Carer [2] | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Acetaminophen | ||||||||||||||||||
Arm description |
Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
acetaminophen
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Investigational medicinal product code |
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Other name |
Paracetamol
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1000mg every 6 hours
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Arm title
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Tramadol | ||||||||||||||||||
Arm description |
Patients received a prescription for tramadol 50mg every 8 hours as needed | ||||||||||||||||||
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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
50mg every 8 hours as needed
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Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: Only subjects were not blinded [2] - The roles blinded appear inconsistent with a simple blinded trial. Justification: No blinding of subjects |
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Baseline characteristics reporting groups
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Reporting group title |
Acetaminophen
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Reporting group description |
Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Tramadol
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Reporting group description |
Patients received a prescription for tramadol 50mg every 8 hours as needed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Acetaminophen
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Reporting group description |
Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours | ||
Reporting group title |
Tramadol
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Reporting group description |
Patients received a prescription for tramadol 50mg every 8 hours as needed |
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End point title |
Satisfaction after pain relief | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
2 weeks post-operative
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Statistical analysis title |
Non-inferiority | ||||||||||||
Statistical analysis description |
Non-inferiority
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Comparison groups |
Tramadol v Acetaminophen
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.78 | ||||||||||||
upper limit |
1.3 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
2 weeks post-operative
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Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
15
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Reporting groups
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Reporting group title |
Acetaminophen
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Reporting group description |
Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours | |||||||||||||||||||||
Reporting group title |
Tramadol
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Reporting group description |
Patients received a prescription for tramadol 50mg every 8 hours as needed | |||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||
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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 |