Clinical Trial Results:
Botulinum Toxin: an adjunct in limb reconstruction – can it reduce pain and joint complications in the lengthening phase?
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Summary
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EudraCT number |
2008-000853-37 |
Trial protocol |
GB |
Global end of trial date |
09 Jun 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Dec 2019
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First version publication date |
21 Dec 2019
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Other versions |
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Summary report(s) |
study summary declaration of end of trial form end of study declaration. Annex 1 |
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 |
SCH/07/006
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Additional study identifiers
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ISRCTN number |
ISRCTN35609758 | ||
US NCT number |
NCT00624299 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sheffield Childrens Hospital NHS Foundation Trust
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Sponsor organisation address |
Western Bank, Sheffield, United Kingdom, S10 2TH
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Public contact |
Dominic Nash
R&D Manager
Sheffield Childrens Hospital NHS Foundation Trust, Sheffield Childrens Hospital NHS Foundation Trust, 44 01143053478, dominic.nash@nhs.net
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Scientific contact |
Dominic Nash
R&D Manager
Sheffield Childrens Hospital NHS Foundation Trust, Sheffield Childrens Hospital NHS Foundation Trust, 44 01143053478, dominic.nash@nhs.net
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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 |
09 Jun 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Jun 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jun 2009
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Does the injection of a single dose of Botulinum toxin reduce pain, protect the stability of the joint and improve function in children who have limb reconstruction surgery (LRS)?
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Protection of trial subjects |
NA
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Background therapy |
Saline is injected into the muscles known to cause problems | ||
Evidence for comparator |
In children undergoing limb reconstruction surgery it is thought that an injection of Botulinum toxin into key muscles reduce pain, maintain the range of motion in the knee and / or ankle joint and enhance their independence and quality of life | ||
Actual start date of recruitment |
31 Mar 2008
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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 |
United Kingdom: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
2
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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 |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Scientific peer review of the protocol raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been recruited | |||||||||
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Pre-assignment
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Screening details |
Scientific peer review of the protocol raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been screened | |||||||||
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Period 1
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Period 1 title |
09/06/2009 (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 |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
Blinding implementation details |
The child, parents, and researcher will be blind to the group allocation only the surgeon will know which child receives the drug. (The preferred method of randomisation would have allowed the surgeon to be blinded too but the logistics of the drug being prepared in pharmacy made it impossible to achieve).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Botox | |||||||||
Arm description |
Botox injection | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Botulinum Toxin
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Investigational medicinal product code |
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Other name |
Botox
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular and intravenous use
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Dosage and administration details |
4-6 units per kilo of body weight
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Investigational medicinal product name |
Saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular and intravenous use
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Dosage and administration details |
is 4-6 units per kilo of body weight
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Arm title
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Placebo | |||||||||
Arm description |
Saline injection is given as a placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular and intravenous use
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Dosage and administration details |
4-6 units per kilo of body weight
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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: Following scientific peer review of the protocol the feedback received raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been recruited therefore there are no adverse implications for this decision. |
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End points reporting groups
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Reporting group title |
Botox
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Reporting group description |
Botox injection | ||
Reporting group title |
Placebo
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Reporting group description |
Saline injection is given as a placebo | ||
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End point title |
pain reduction in knee and ankle joint [1] | |||||||||
End point description |
In children undergoing limb reconstruction surgery will the injection of Botulinum toxin into key muscles reduce the pain, maintain the range of motion in the knee and / or ankle joint and enhance their independence and quality of life?
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End point type |
Primary
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End point timeframe |
End of study
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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: Following scientific peer review of the protocol the feedback received raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been recruited therefore there are no adverse implications for this decision. |
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| Notes [2] - Following peer review advice the decision was taken not to proceed with the trial [3] - Following peer review advice the decision was taken not to proceed with the trial |
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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 |
Following peer review advice the decision was taken not to proceed with the trial. No participants have been recruited therefore there are no adverse events arose
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
EDMS | ||
Dictionary version |
1
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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: Following scientific peer review of the protocol the feedback received raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been recruited therefore there are no adverse implications for this decision. |
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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 | |||
