Clinical Trial Results:
A comparison of the clinical efficacies of Fusidic acid hydrophilic cream 20 mg/g and Fucidin in the treatment of adult and paediatric patients with impetigo
Summary
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EudraCT number |
2006-002528-41 |
Trial protocol |
NL BE |
Global end of trial date |
13 Aug 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jan 2020
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First version publication date |
02 Jan 2020
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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 |
BPT05-641
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Interdos Pharma bv
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Sponsor organisation address |
Burgemeester Lemmensstraat 352, Geleen, Netherlands, 6163JT
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Public contact |
Jos Wesselman, Interdos, +31 882554010, j.wesselman@basicpharma.nl
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Scientific contact |
Jos Wesselman, Interdos, +31 882554010, j.wesselman@basicpharma.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 |
13 Aug 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Aug 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Aug 2009
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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 goal of this study is to assess whether the clinical efficacy and safety of Fusidic acid hydrophilic cream 20 mg/g, manufactured by Basic Pharma Manufacturing bv, and Fucidin are equivalent in a 7-day treatment of impetigo in adult and paediatric subjects.
Primary outcome: cure after 1 week. Cure is defined as the complete absence of lesions or the lesions having become dry and without crusts; remaining local erythema of the intact skin is acceptable.
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Protection of trial subjects |
Not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Sep 2006
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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 |
Netherlands: 92
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Country: Number of subjects enrolled |
Belgium: 69
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Country: Number of subjects enrolled |
Serbia: 15
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Worldwide total number of subjects |
176
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EEA total number of subjects |
161
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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) |
3
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Children (2-11 years) |
66
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Adolescents (12-17 years) |
33
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Adults (18-64 years) |
63
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment: The Netherlands: 11 September 2006 - 10 April 2009 Belgium: 18 December 2007 - 23 July 2009 Serbia: 06 February 2009 - 30 July 2009 | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Not applicable. Patients with impetigo who are visiting the investigator and who comply with the inclusion criteria were be asked to participate in the study. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overal 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 | |||||||||||||||||||||||||||
Blinding implementation details |
Reference product (cream) was repacked in blank tubes
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fusidic acid hydrophilic cream 20 mg/g | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Fusidic acid hydrophilic cream 20 mg/g
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
It was not possible to establish a predefined amount of study cream that should be applied to the affected skin, because it depends on a number of variables such as number of skin lesions, size (surface area) of the lesions, location of the lesions, and age of the subject. It was left to the medical judgement of the investigator to establish the amount of cream required for a proper treatment of each patient.
The investigators and patients were provided with dosing cards, adapted from the innovator’s website, in order to assist the investigators in the determination and communication of the amount of study cream that should be applied, and in an effort to standardize the procedure of determining the dose of study medication.
The dose is given in terms of finger tip units. One finger tip unit is: One full finger tip of cream, this equals approximately 0.5 gram
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Arm title
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Fucidin® cream | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||
Investigational medicinal product name |
Fucidin® cream
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
It was not possible to establish a predefined amount of study cream that should be applied to the affected skin, because it depends on a number of variables such as number of skin lesions, size (surface area) of the lesions, location of the lesions, and age of the subject. It was left to the medical judgement of the investigator to establish the amount of cream required for a proper treatment of each patient.
The investigators and patients were provided with dosing cards, adapted from the innovator’s website, in order to assist the investigators in the determination and communication of the amount of study cream that should be applied, and in an effort to standardize the procedure of determining the dose of study medication.
The dose is given in terms of finger tip units. One finger tip unit is: One full finger tip of cream, this equals approximately 0.5 gram
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Baseline characteristics reporting groups
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Reporting group title |
Fusidic acid hydrophilic cream 20 mg/g
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Reporting group description |
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Reporting group title |
Fucidin® cream
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Reporting group description |
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End points reporting groups
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Reporting group title |
Fusidic acid hydrophilic cream 20 mg/g
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Reporting group description |
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Reporting group title |
Fucidin® cream
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Reporting group description |
- |
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End point title |
“cure” at week one | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 week
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Attachments |
Cure at one week |
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Statistical analysis title |
Non-inferiority analysis for "cure" at one week | |||||||||
Statistical analysis description |
This will be a double-blind non-inferiority trial aimed to demonstrate that the test cream is as effective the reference cream (Fucidin® cream). For this purpose it is assumed that a demonstration that 50% or more of the efficacy of fusidic acid versus placebo is maintained will suffice to accept non-inferiority. The primary efficacy analysis is the rate of “Cure” at one week. Previous studies demonstrated that with placebo the rate of cure was 13% at this point in time, versus 55% with the appl
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Comparison groups |
Fusidic acid hydrophilic cream 20 mg/g v Fucidin® cream
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Number of subjects included in analysis |
172
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
Method |
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Parameter type |
proportion cured at one week | |||||||||
Point estimate |
0.975
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Confidence interval |
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95% | |||||||||
sides |
1-sided
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lower limit |
0.2 | |||||||||
upper limit |
- |
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End point title |
“cure” at week two | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
2 weeks
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Attachments |
Cure at two weeks |
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No statistical analyses for this end point |
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End point title |
bacterial cure at week one | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 week
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No statistical analyses for this end point |
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End point title |
bacterial cure at week two | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
2 weeks
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No statistical analyses for this end point |
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End point title |
"Improvement" at week one | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 week
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No statistical analyses for this end point |
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End point title |
"Failure" at week one | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 week
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
1 week, 2 weeks
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Adverse event reporting additional description |
Adverse events are collected during the follow-up visits after 1 week and after 2 weeks, and reported in the Case Report Forms.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11
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Reporting groups
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Reporting group title |
Fusidic acid hydrophilic cream 20 mg/g
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fucidin® cream
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Reporting group description |
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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? 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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/11809642 |