Clinical Trial Results:
Evaluation of the speed of action of Ibuprofen Arginine in comparison to Ibuprofen in the acute pain relief after mini invasive orthopaedic arthroscopic knee surgery in adults.
Summary
|
|
EudraCT number |
2011-003051-19 |
Trial protocol |
IT |
Global end of trial date |
15 Jul 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
17 Dec 2016
|
First version publication date |
17 Dec 2016
|
Other versions |
|
Summary report(s) |
CSR synopsis 7190M01 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
Z7190M01
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Zambon SpA
|
||
Sponsor organisation address |
via Lillo Del Duca 10, Bresso, Italy,
|
||
Public contact |
Sponsor Contact Person, Zambon S.p.A., 39 026652.41, clinicaltrials@zambongroup.com
|
||
Scientific contact |
Sponsor Contact Person, Zambon S.p.A., 39 026652.41, massimo.bagolan@zambongroup.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 Apr 2015
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
15 Jul 2014
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
To assess the speed of action and global clinical efficacy of ibuprofen arginine (IBA) in comparison with ibuprofen (IBU) in patients with postoperative acute pain.
|
||
Protection of trial subjects |
Paracetamol 500 mg tablets were allowed as rescue medication after the first 60 minutes from the study medication intake, and during the following period of study observation according to medical prescription
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Mar 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Italy: 43
|
||
Worldwide total number of subjects |
43
|
||
EEA total number of subjects |
43
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
43
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||
Recruitment
|
||||||||||
Recruitment details |
The study population was targeted to include male and female subjects suffering from post-operative acute pain due to mini invasive orthopaedic arthroscopic surgery (meniscectomy) and meeting all the inclusion and exclusion criteria | |||||||||
Pre-assignment
|
||||||||||
Screening details |
Subjects candidate for elective meniscectomy were enrolled at Orthopedic departments | |||||||||
Period 1
|
||||||||||
Period 1 title |
Treatment period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Single blind | |||||||||
Roles blinded |
Assessor [1] | |||||||||
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
Arm title
|
Ibuprofen arginine | |||||||||
Arm description |
Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ibuprofen arginie
|
|||||||||
Investigational medicinal product code |
7190
|
|||||||||
Other name |
||||||||||
Pharmaceutical forms |
Granules for oral solution
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
single dose of one sachet 600 mg given by oral route (dissolved in 50 - 100 ml of water) in the post-surgical period
|
|||||||||
Arm title
|
Ibuprofen | |||||||||
Arm description |
Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ibuprofen
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Granules for oral solution
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
single dose of one sachet 600 mg given by oral route (dissolved in 50 - 100 ml of water) in the post-surgical period
|
|||||||||
Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Only the evaluating investigator (observer) was blinded to the treatment administered. |
||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ibuprofen arginine
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ibuprofen
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Safety set
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
all subjects randomized and treated with one dose of IMP
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Ibuprofen arginine
|
||
Reporting group description |
Ibuprofen Arginine (IBA) apricot 600 mg granules for oral solution (sachets); single dose of one sachet | ||
Reporting group title |
Ibuprofen
|
||
Reporting group description |
Ibuprofen (IBU) orange 600 mg granules for oral solution (sachets) | ||
Subject analysis set title |
Safety set
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
all subjects randomized and treated with one dose of IMP
|
|
|||||||||||||
End point title |
Onset of pain relief [1] | ||||||||||||
End point description |
The primary endpoint of the study was the time to onset of pain relief (when the subject began to feel any pain relieving effect from the drug) in the first 60 minutes after study medication intake. The effect of IBA or IBU was assessed, for this first 60 minute observation period, in absence of intake of any rescue medication, using a stopwatch clock
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
0-360 minutes
|
||||||||||||
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: The study was prematurely terminated and therefore the sample size is not sufficient for a statistical analysis. Only mean values and SD are reported. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
achievement of at least 50% pain relief | |||||||||||||||
End point description |
The proportion of subjects with at least 50% pain relief
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
0-60 minutes
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Meaningful pain relief | |||||||||||||||
End point description |
The time to achievement of the “meaningful pain relief” (when the subject felt his/her pain relief was meaningful) using a stopwatch clock
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
0-360 minutes
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Clinical Global Impression | |||||||||||||||||||||
End point description |
The Clinical Global Impression (CGI) of the subject at the end of the study, using a 7-point scale
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
0-360 minutes
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From signature of Informed Consent to end of study.
|
|||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
16.1
|
|||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Ibuprofen arginine
|
|||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Ibuprofen
|
|||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |