Clinical Trial Results:
Randomized, placebo-controlled, parallel group, double-blind, multi-center Phase III study to assess the inhibition of plaque formation of 0.1% octenidine mouthwash vs placebo in subjects with a gingival index ≤1.5
Summary
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EudraCT number |
2017-001698-18 |
Trial protocol |
DE AT |
Global end of trial date |
14 Sep 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Apr 2020
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First version publication date |
05 Apr 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 |
OML-III-B
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03378401 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Schülke & Mayr GmbH
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Sponsor organisation address |
Robert-Koch-Straße 2, Norderstedt, Germany, 22851
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Public contact |
Clinical trials information, Schülke & Mayr GmbH, Schülke & Mayr GmbH, +49 40 52100-0, info@schuelke.com
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Scientific contact |
Clinical trials information, Schülke & Mayr GmbH, Schülke & Mayr GmbH, +49 40 52100-0, info@schuelke.com
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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 |
14 Sep 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Sep 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Sep 2018
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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 |
Demonstration of superiority of 0.1% octenidine mouthwash (OML, “Octenidin Mundspüllösung”) to placebo in the inhibition of plaque formation
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Protection of trial subjects |
The study was performed in accordance with the International Council on Harmonisation (ICH) Guideline
for Good Clinical Practice (GCP, CPMP/ICH/135/95), the appropriate national regulations and the
Declaration of Helsinki.
Before any study-related procedures were performed, the investigator obtained written informed
consent from all subjects. The investigator ensured that the subject was fully informed (verbally and in
writing) about the aims, procedures, potential risks, discomforts, and expected benefits of the clinical
study. The subject had ample time to ask questions and to decide whether or not to participate.
Only subjects that met all study inclusion criteria and none of the exclusion criteria were entered in the
study. Participation in the study was voluntary and all subjects had the right to withdraw from the
clinical study at any time and for any reason without any disadvantages for their medical care.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Jan 2018
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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 |
Austria: 33
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Country: Number of subjects enrolled |
Germany: 67
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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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) |
100
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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 |
Subjects were enrolled at 2 centers in Germany and 1 center in Austria. The first subject signed the informed consent form on 11-Jan-2018 and the last subject completed the study on 14-Sep-2018. | |||||||||||||||
Pre-assignment
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Screening details |
A total of 114 subjects were screened, of whom 14 subjects were screening failures. | |||||||||||||||
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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OML arm | |||||||||||||||
Arm description |
0.1% octenidine mouthwash (OML) | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
0.1% octenidine mouthwash
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Investigational medicinal product code |
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Other name |
OML
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Pharmaceutical forms |
Mouthwash
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Routes of administration |
Oromucosal use
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Dosage and administration details |
Subjects performed 10 applications of OML (mouth rinse with 10 mL OML for 30 s) over 5 days (3 times
on Day 1, twice daily on Days 2-4, once on Day 5).
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Arm title
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Placebo arm | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Mouthwash
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Routes of administration |
Oromucosal use
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Dosage and administration details |
Subjects performed 10 applications (mouth rinse with 10 mL placebo for 30 s) over 5 days (3 times on
Day 1, twice daily on Days 2-4, once on Day 5).
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Baseline characteristics reporting groups
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Reporting group title |
OML arm
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Reporting group description |
0.1% octenidine mouthwash (OML) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo arm
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
OML arm
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Reporting group description |
0.1% octenidine mouthwash (OML) | ||
Reporting group title |
Placebo arm
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Reporting group description |
- |
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End point title |
Total mean plaque index after 5 days of treatment at Visit 2 [1] | ||||||||||||
End point description |
The thickness and extension of plaque along the gingival margin were assessed using the plaque
index (PI) according to Silness and Löe, 1964. Evaluation of the PI was limited to “Ramfjord teeth” (16,
21, 24, 36, 41, 44 or their replacement teeth 17, 11, 25, 37, 31, 45). For each of the 4 surfaces a grade
from 0 to 3 was given. The total mean PI was the sum of the individual grades divided by the number of
investigated sites.
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End point type |
Primary
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End point timeframe |
Day 5
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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: Results of the statistical analysis could not be entered in the system. The superiority of OML over placebo in inhibiting plaque formation was demonstrated using the van Elteren test stratified by gingival status at Visit 1 and center (1-sided p-value <0.0001; point estimate -0.88 [median difference, OML minus placebo]). |
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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 |
From time of first study drug administration (Day 1) until end of treatment (completion of study, Day 5).
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
OML arm
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Reporting group description |
0.1% octenidine mouthwash (OML) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo arm
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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? Yes | |||||||
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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 |