Clinical Trial Results:
Therapeutic clinical trial of three types of “Phlogosol concentrate for gargle” products, comparing their efficacy in reducing different inflammations of the oral cavity.
(Changing the active ingredient of “Phlogosol concentrate for gargle” of oral cavity from hexachlorophene to chlorhexidine, the two products with different active ingredients in a non-inferiority clinical trial in comparison to the third control product.)
Summary
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EudraCT number |
2013-002190-22 |
Trial protocol |
HU |
Global end of trial date |
21 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Jul 2016
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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 |
Phlogosol_2013/01
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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) |
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Sponsors
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Sponsor organisation name |
PannonPharma Ltd.
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Sponsor organisation address |
PannonPharma ut 1., Pecsvarad, Hungary, 7720
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Public contact |
Head of Research and Development Department, PannonPharma Ltd., clinical.trials@pannonpharma.hu
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Scientific contact |
Head of Research and Development Department, PannonPharma Ltd., clinical.trials@pannonpharma.hu
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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 |
16 Jun 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Oct 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 |
Cure or healing improvement in inflammations of oral cavity mucosa
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Protection of trial subjects |
This study was conducted in accordance with Good Clinical Practice standards, and ethical principles stated in the Declaration of Helsinki. All study participants were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Aug 2014
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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 |
Hungary: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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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) |
62
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From 65 to 84 years |
18
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants took part in the study at 1 investigational site located in Hungary, from 11 Aug 2014 to 21 Oct 2014. | ||||||||||||||||||||
Pre-assignment
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Screening details |
Patients of both sexes aged 18 years or older suffering from local inflammatory changes of the oral cavity | ||||||||||||||||||||
Period 1
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Period 1 title |
Treatment period (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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Phlogosol Solution | ||||||||||||||||||||
Arm description |
Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Phlogosol Solution for external use only
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Investigational medicinal product code |
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Other name |
Phlogosol külsőleges oldat
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Pharmaceutical forms |
Concentrate for gargle
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Routes of administration |
Oromucosal use, Oropharyngeal use
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Dosage and administration details |
Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
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Arm title
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Phlogosol Uno | ||||||||||||||||||||
Arm description |
Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Phlogosol Uno 30 mg/ml concentrate for gargle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for gargle
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Routes of administration |
Oromucosal use, Oropharyngeal use
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Dosage and administration details |
Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
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Arm title
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Phlogosol Duo | ||||||||||||||||||||
Arm description |
Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Phlogosol Duo 30 mg/2 mg/ml concentrate for gargle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for gargle
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Routes of administration |
Oromucosal use, Oropharyngeal use
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Dosage and administration details |
Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
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Baseline characteristics reporting groups
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Reporting group title |
Phlogosol Solution
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Reporting group description |
Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Phlogosol Uno
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Reporting group description |
Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Phlogosol Duo
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Reporting group description |
Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Phlogosol Solution
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Reporting group description |
Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||
Reporting group title |
Phlogosol Uno
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Reporting group description |
Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||
Reporting group title |
Phlogosol Duo
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Reporting group description |
Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. |
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End point title |
Reduction in the size of inflamed area | ||||||||||||||||
End point description |
Area of inflammation in oral cavity was measured at Baseline (Visit 1) and after 7 days treatment (Visit 2). Changing in size of inflamed area from Visit 1 to Visit 2 was calculated. Negative values show decrease and positive values show increase in size of inflamed area, 0 represents no change.
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End point type |
Primary
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End point timeframe |
From Baseline (Visit 1) to Day 7 (Visit 2)
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Statistical analysis title |
Non-inferiority analysis | ||||||||||||||||
Statistical analysis description |
Since data from different groups did not show normal distributions, in order to comparison of reduction in the size of inflamed area in group-pairs Mann-Whitney U-test (nonparametric counterpart of unpaired sample t-test) was used. Because of multiple comparisons Bonferroni correction was applied. Primary end point was to investigate non-inferiority of Phlogosol Duo and Phlogosol Solution. P-values for other group-pair comparisons see in Notes.
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Comparison groups |
Phlogosol Solution v Phlogosol Uno v Phlogosol Duo
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Number of subjects included in analysis |
71
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||
P-value |
= 0.45 [1] | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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Notes [1] - P-value for Phlogosol solution and Phlogosol Uno comparison p=0.500 P-value for Phlogosol Duo and Phlogosol Uno comparison p=0.702 Significance threshold is p<0.017 with Bonferroni correction |
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End point title |
Extent, painfulness and degree of inflammation | ||||||||||||||||||||||||||||
End point description |
Extent, painfulness and degree of inflammation were assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
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End point type |
Secondary
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End point timeframe |
At Baseline (Visit 1) and after 7 days treatment (Visit 2)
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No statistical analyses for this end point |
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End point title |
Status of oral hygiene | ||||||||||||||||||||||||||||||||||||
End point description |
Status of oral hygiene was assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
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End point type |
Secondary
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End point timeframe |
At Baseline (Visit 1) and after 7 days treatment (Visit 2)
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No statistical analyses for this end point |
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End point title |
Degree of pain | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Degree of pain was assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
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End point type |
Secondary
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End point timeframe |
At Baseline (Visit 1) and after 7 days treatment (Visit 2)
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Notes [2] - Visit 1 (N=25), Visit 2 (N=24) |
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No statistical analyses for this end point |
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End point title |
Degree of pain on VAS (Visual analog scale) | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
On the VAS scale: 0 cm = no pain and 10 cm = extreme pain
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End point type |
Secondary
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End point timeframe |
At Baseline and during the 7 day period of treatment (Day 1-7)
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Notes [3] - At the end of treatment N=23 [4] - At the end of treatment N=24 |
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No statistical analyses for this end point |
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End point title |
Hyperaemia, Swelling, Erosio, Ulceratio | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Incidence of Hyperaemia, Swelling, Erosio and Ulceration were assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
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End point type |
Secondary
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End point timeframe |
At Baseline (Visit 1) and after 7 days treatment (Visit 2)
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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 |
During the entire study period
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19
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Reporting groups
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Reporting group title |
Phlogosol Solution
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Reporting group description |
Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Phlogosol Uno
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Reporting group description |
Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Phlogosol Duo
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Reporting group description |
Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3.5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |