Clinical Trial Results:
A randomised, double-blind, multi-centre, placebo controlled parallel group study to evaluate the efficacy and tolerability of a new Ibuprofen patch in patients with acute sports related traumatic blunt soft tissue injury/contusion to the upper or lower limbs
Summary
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EudraCT number |
2012-003257-29 |
Trial protocol |
DE |
Global end of trial date |
02 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jun 2017
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First version publication date |
28 Jun 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 |
NL1208
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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 |
Reckitt Benckiser Healthcare (UK) Ltd
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Sponsor organisation address |
Dansom Lane, Hull, United Kingdom, HU8 7DS
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Public contact |
Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Ltd, 49 2282074318,
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Scientific contact |
Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Ltd, 49 2282074318,
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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 |
24 Sep 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Mar 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 |
The primary objective of the study is to assess the efficacy of a new ibuprofen patch versus placebo in the topical treatment of acute sports impact injuries/contusions.
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Protection of trial subjects |
This study was conducted in accordance with ICH Good Clinical Practice and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 May 2013
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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 |
Germany: 132
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Worldwide total number of subjects |
132
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EEA total number of subjects |
132
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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) |
132
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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 |
The trial was conducted in 3 centres in Germany. | |||||||||||||||
Pre-assignment
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Screening details |
A total of 133 participants were screened of which 132 were randomized and 1 subject withdrew due to Psychotic illness (depression). | |||||||||||||||
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 |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ibuprofen topical patch 200 mg | |||||||||||||||
Arm description |
Ibuprofen Topical patch 200 mg for 5 days | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nurofen topical patch
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Investigational medicinal product code |
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Other name |
Ibuprofen topical patch
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Pharmaceutical forms |
Medicated plaster
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Routes of administration |
Topical use
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Dosage and administration details |
Ibuprofen Topical patch 200 mg once every 24 hours for 5 days
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Arm title
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Placebo topical patch | |||||||||||||||
Arm description |
Placebo topical patch for 5 days | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo topical patch
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicated plaster
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Routes of administration |
Topical use
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Dosage and administration details |
Placebo topical patch once every 24 hours for 5 days
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Baseline characteristics reporting groups
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Reporting group title |
Ibuprofen topical patch 200 mg
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Reporting group description |
Ibuprofen Topical patch 200 mg for 5 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo topical patch
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Reporting group description |
Placebo topical patch for 5 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ibuprofen topical patch 200 mg
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Reporting group description |
Ibuprofen Topical patch 200 mg for 5 days | ||
Reporting group title |
Placebo topical patch
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Reporting group description |
Placebo topical patch for 5 days |
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End point title |
VAS assessment of pain on movement - Area under curve over 0-72 hours (AUC0-72h) | ||||||||||||
End point description |
Intention to treat (ITT) population: All patients who were randomised to the study and received at least one dose of the study medication and had efficacy data for at least one post-baseline assessments.
Pain on movement was assessed using a 100 mm Visual Analogue Scale (VAS), by drawing a perpendicular line according to the method of Huskisson, with anchors at 0 = 'No pain' and 100 = 'Unbearable pain'.
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End point type |
Primary
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End point timeframe |
0 (pre-dose) to 72 hour (post-dose)
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Statistical analysis title |
Pain on movement - VAS AUC0-72h | ||||||||||||
Comparison groups |
Ibuprofen topical patch 200 mg v Placebo topical patch
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
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End point title |
VAS assessment of pain on movement at Hour 48 | ||||||||||||
End point description |
ITT population.
Pain on movement was assessed using a 100 mm Visual Analogue Scale (VAS), by drawing a perpendicular line according to the method of Huskisson, with anchors at 0 = 'No pain' and 100 = 'Unbearable pain'.
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End point type |
Secondary
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End point timeframe |
At 48 hour (post-dose)
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Statistical analysis title |
Pain on movement - VAS at hour 48 | ||||||||||||
Comparison groups |
Ibuprofen topical patch 200 mg v Placebo topical patch
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Day 5
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Ibuprofen topical patch 200 mg
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Reporting group description |
Ibuprofen Topical patch 200 mg once every 24 hours for 5 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo topical patch
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Reporting group description |
Placebo topical patch once every 24 hours for 5 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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20 Feb 2013 |
Protocol updated to stipulate there was a separate dispenser/applier at each site who was not the investigator and that the delegated personnel who did not perform any efficacy assessments was responsible for the handling, storage, dispensing, collecting and administration of the IMP/NIMP |
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17 Oct 2013 |
The update to the RB SOP ‘Safety Reporting and Definitions’ required an amendment to the RB protocol template and therefore updates to the protocols for On going trials |
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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 |