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    Clinical Trial Results:
    Multicenter, randomized, double-blind, comparative with reference product clinical trial to evaluate the efficacy and safety of treatment with Clindamycin vaginal suppositories 100 mg in patients with bacterial vaginosis

    Summary
    EudraCT number
    		 2011-002386-38
    Trial protocol
    		 GR  
    Global end of trial date
    19 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2017
    First version publication date
    04 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLVS100VER
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Verisfield (UK) Ltd
    Sponsor organisation address
    8 Vironos Street, Halandri/Athens, Greece,
    Public contact
    Clinical Research Scientist, Antonios Margaritis, VERISFIELD (UK) LTD, 0030 2107475196, info@verisfield.gr
    Scientific contact
    Clinical Trial Department, Verisfield (UK) Ltd, Greek Branch, VERISFIELD (UK) LTD, 0030 2107475196, info@verisfield.gr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was the comparison of: (a) the efficiency, and (b) the safety of local treatment with clindamycin vaginal suppositories of Verisfield (UK) Ltd (Clindamycin/Verisfield, vaginal suppositories, 100 mg) and the therapeutic comparison with the reference product (Dalacin/Pfizer, vaginal suppositories, 100 mg), in women with bacterial vaginosis.  
    Protection of trial subjects
    This study was conducted in accordance with International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines adopted by the European Medicines Agency (EMA). In accordance with local requirements, the study was submitted to the National Ethics Committee and the National Drug Organization for approval. The study begun only when Verisfield (UK) Ltd had received a copy of the written approval from the National Drug Organization. The conduct of the study was done in accordance with the relevant requirements of the National Drug Organization. Moreover, the involvement of patients in this study were reported to the Data Protection Authority in accordance with European Union Directive 95/46/EC and the Directives/laws of each country.Finally, the study has been designed according to the European Directives 2001/20/EC and 2005/28/EC and Directives ICH E1-E3 and E5-E11. Physical examination and an assessment of vital signs (blood pressure, pulse rate, temperature) were performed during the screening, as well as during all the study visits for all the participating volunteers. Moreover, adverse events (AEs) were observed during the entire study period and adequately handled and reported. Furthermore, a urine human chorionic gonadotropin (hCG) test was performed for all females of childbearing potential during all study Visits. Finally, all volunteers participating in this clinical study were covered by insurance on behalf of the sponsor.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants were selected among adult premenopausal female patients with bacterial vaginosis, volunteers, aged 18-54 years (including the limits) that attended/visited the hospitals of the study sites

    Pre-assignment
    Screening details
    		 Adult premenopausal female patients with bacterial vaginosis, volunteers, aged 18-54 years (including the limits). Other inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test
    Arm description
    		 The subjects were administered with the experimental medicinal product.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin/Verisfield 100 mg vaginal suppositories
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Vaginal use
    Dosage and administration details
    The route of administration, dosage, dosage regimen and duration of treatment was in accordance with the summary of product characteristics of the original formulation (reference product). The dosage regimen was one suppository for three consecutive days, before bedtime.

    Arm title
    		 Reference
    Arm description
    		 The subjects were administered with the reference product.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dalacin/Pfizer 100 mg vaginal suppositories
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Vaginal use
    Dosage and administration details
    The dosage regimen was one suppository for three consecutive days, before bedtime.

    Number of subjects in period 1
    		Test Reference
    Started
    3
    3
    Completed
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 The subjects were administered with the experimental medicinal product.

    Reporting group title
    Reference
    Reporting group description
    		 The subjects were administered with the reference product.

    Primary: Efficacy -The cure of the patients defined as the absence of three or four criteria of Amsel (existence of one or none criterion) in the 2nd visit.

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    End point title
    		 Efficacy -The cure of the patients defined as the absence of three or four criteria of Amsel (existence of one or none criterion) in the 2nd visit. [1]
    End point description
    The Amsel criteria are the following four: 1. Homogeneous, white, attaching vaginal discharge (often with fishy smell). 2. Positive amine check (characteristic odor of fish by applying 10% KOH - whiff test). 3. pH> 4.5. 4. Presence of clue cells (epithelial cells covered by coccobacillary organisms) in wet mount of vaginal secretion.
    End point type
    Primary
    End point timeframe
    The Amsel criteria for the primary endpoint were assessed in the 2nd visit (7-12 days after the beginning of the treatment)
    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: In the context of the present study, 10 volunteers were screened, of which 6 who met the eligibility criteria, were enrolled in the study and received one of the IMPs. Since the number of the enrolled volunteers was very low, no statistical analysis could be performed.
    End point values
    		 Test Reference
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Confidence interval
    Notes
    [2] - Very low enrollment rate.No statistical analysis could be performed
    [3] - Very low enrollment rate.No statistical analysis could be performed
    No statistical analyses for this end point

    Secondary: IGII (Patient Global Improvement Index)

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    End point title
    		 IGII (Patient Global Improvement Index)
    End point description
    Clinical evaluation of vaginitis based on the progression of symptoms by the investigator. The assessment is done using the following scale: Serious deterioration (-2), Mild deterioration (-1), no change (0), mild improvement (1), moderate improvement (2), significant improvement (3), complete improvement (4).
    End point type
    Secondary
    End point timeframe
    The IGII (Patient Global Improvement Index) was assessed in the 2nd visit (7-12 days after the beginning of the treatment) and in the 3rd visit (21-30 days after the beginning of the treatment)
    End point values
    		 Test Reference
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: IGII
        number (not applicable)
    Notes
    [4] - Very low enrollment rate. No statistical analysis could be performed.
    [5] - Very low enrollment rate. No statistical analysis could be performed.
    No statistical analyses for this end point

    Secondary: Efficacy_The cure of patients based to Amsel and Nugent criteria in the 2nd and 3rd visit

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    End point title
    		 Efficacy_The cure of patients based to Amsel and Nugent criteria in the 2nd and 3rd visit
    End point description
    The cure of patients was based on the absence of three or four Amsel criteria at Visit 3 and on the absence of three or four Amsel criteria and score <7 in Nugent scale in 2nd and 3rd visit. The Amsel criteria are the following four: 1. Homogeneous, white, attaching vaginal discharge (often with fishy smell). 2. Positive amine check (characteristic odor of fish by applying 10% KOH - whiff test). 3. pH> 4.5. 4. Presence of clue cells (epithelial cells covered by coccobacillary organisms) in wet mount of vaginal secretion. The Nugent method include: 1 loss of lactobacilli (score 0-4) 2 increase in the number of gram (+) and gram (-) coccobacillus (especially Gardnerella vaginalis, score 0-4) 3 Increase in the number of Mobi luncus spp (score 0-2) These scores are added and based to their sum, the condition is assessed. • The score of 0-3 is considered normal flora • The score of 4-6 as intermediate
    End point type
    Secondary
    End point timeframe
    The Amsel and Nugent criteria were assessed in the 2nd (7-12 days after the beginning of the treatment) and 3rd visit (21-30 days after the beginning of the treatment).
    End point values
    		 Test Reference
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Confidence Interval
    Notes
    [6] - Very low enrollment rate.No statistical analysis could be performed
    [7] - Very low enrollment rate.No statistical analysis could be performed
    No statistical analyses for this end point

    Secondary: PGII (Patient Global Improvement Index)

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    End point title
    		 PGII (Patient Global Improvement Index)
    End point description
    Clinical evaluation of vaginitis by the patient, based on the progression of symptoms. The assessment is done using the following scale: Serious deterioration (-2), Mild deterioration (-1), no change (0), mild improvement (1), moderate improvement (2), significant improvement (3), complete improvement (4).
    End point type
    Secondary
    End point timeframe
    The PGII (Patient Global Improvement Index) was assessed in the 2nd visit (7-12 days after the beginning of the treatment) and in the 3rd visit (21-30 days after the beginning of the treatment)
    End point values
    		 Test Reference
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: PGII
        number (not applicable)
    Notes
    [8] - Very low enrollment rate. No statistical analysis could be performed.
    [9] - Very low enrollment rate. No statistical analysis could be performed.
    No statistical analyses for this end point

    Secondary: Efficacy -The cure of the patients defined as the absence of three or four criteria of Amsel (existence of one or none criterion) in the 3rd visit

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    End point title
    		 Efficacy -The cure of the patients defined as the absence of three or four criteria of Amsel (existence of one or none criterion) in the 3rd visit
    End point description
    The Amsel criteria are the following four: 1. Homogeneous, white, attaching vaginal discharge (often with fishy smell). 2. Positive amine check (characteristic odor of fish by applying 10% KOH - whiff test). 3. pH> 4.5. 4. Presence of clue cells (epithelial cells covered by coccobacillary organisms) in wet mount of vaginal secretion.
    End point type
    Secondary
    End point timeframe
    The Amsel criteria were assessed in the 3rd visit (21-30 days after the beginning of the treatment).
    End point values
    		 Test Reference
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Condifence interval
    Notes
    [10] - Very low enrollment rate. No statistical analysis could be performed.
    [11] - Very low enrollment rate. No statistical analysis could be performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The duration of the overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    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: None of the enrolled volunteers (6 in total) developed any adverse event during their participation in the study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2012
    The modification was the addition of an extra visit 21-30 days after the start of the treatment (Visit 3), and the introduction of Nugent criteria on efficacy assessments in the 2nd and 3rd visit. This results in the addition of three additional secondary efficacy parameters: 1. The healing of patients under the Amsel criteria at Visit 3 2. The therapeutic effect based on the Amsel criteria and Nugent score at the second visit. 3. The therapeutic effect based on the Amsel criteria and Nugent score at the 3rd visit.
    11 Feb 2014
    This amendment included: 1. Amendment of the study protocol by 3rd Edition dated 08/03/2013 in 4th Edition dated 28/11/2013. 2. Modification of Informed Consent Form for volunteers participating in the study from 2nd Edition dated 14/03/2012 in 3rd Edition dated 28/11/2013. 3. Change of Principal Investigator in already existing Centre. More specifically, there was a replacement of the Principal Investigator of the already participating Centre (A Obstetrics-Gynecology Clinic, University of Athens, General Hospital of Athens "Alexandra") Professor Aristides Antsaklis by Associate Professor Alexandros Rodolakis. 4. Add of an additional center. More specifically, the study incorporated the VI Obstetrics-Gynecology Clinic Regional General Hospital-Maternity Hospital "Elena Venizelou" with Principal Investigator the obstetrician-gynecologist Mr. George Farmakides. 5. Extension of the study duration from 12 to 36 months.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    19 Oct 2015
    In February 2014, a request for a substantial modification was made to the Greek National Authority of Medicines (EOF) and the National Ethics Committee (EED). The amendment was requested in order to prolong the duration of the study to the already participating center (1st Clinic of Obstetrics and Gynecology, Hospital "Alexandra") for one year and to add a second center in the study (6th Clinic of Obstetrics and Gynecology, Hospital "Elena Venizelou"). However, there were some delays during the approval procedure, mainly because of a change to the Board of Directors of the two involved hospitals and a consequent absence of meetings during that period (1st semester of 2014). As a consequence, the last approvals for this amendment were received in the last trimester of 2014; thus, the remaining time until the end of the requested extension (December 2014) was very limited. On the other hand, at the already participating center (1st Clinic of Obstetrics and Gynecology, Hospital "Alexandra"), a great difficulty in enrolling patients into the study was already noted. This resulted in a very low enrolment rate as well as in difficulty to be compliant with the recruitment timelines and to achieve the expected number of enrolled patients. Further to the above, in January 2015 it was decided to prematurely terminate the study in the first center of the study (1st Clinic of Obstetrics and Gynecology, Hospital "Alexandra"). The second center of the study (6th Clinic of Obstetrics and Gynecology, Hospital "Elena Venizelou") was not activated, since a further amendment was needed to extend the time duration of the study and because of the difficulty to find and enroll patients according to the protocol eligibility criteria that had been encountered in the first center of the study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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