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    Clinical Trial Results:
    Randomized, multicenter, placebo-controlled, double blind study to assess the efficacy and tolerability of 2% diltiazem hydrochloride in the treatment of chronic anal fissure and a 24 week follow-up period

    Summary
    EudraCT number
    		 2015-003627-54
    Trial protocol
    		 CZ   ES  
    Global end of trial date
    21 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    150601
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tecnimede, Sociedade Técnico-Medicinal, S.A.
    Sponsor organisation address
    Zona Industrial da Abrunheira, R. da Tapada Grande, nº 2, Sintra, Portugal, 2710-089
    Public contact
    Medical Department, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210 414 100, dmed.ct@tecnimede.pt
    Scientific contact
    Medical Department, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210 414 100, dmed.ct@tecnimede.pt
    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
    21 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this clinical trial was to assess the relative efficacy (cure of chronic anal fissure) of the DTZ 2% cutaneous paste compared to placebo, in the treatment of chronic anal fissure (CAF), for up to 12 weeks (cure defined as complete closing evaluated through physical examination and re-epithelialization of the anal fissure observed in the anoscopy).
    Protection of trial subjects
    Paracetamol (acetaminophen) and Clonixin were allowed as rescue medication for the shortest possible time. In case the investigator considered that the patient needed other types of rescue medication for the anal fissure, the patient would be withdrawn from the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2017
    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
    Portugal: 12
    Country: Number of subjects enrolled
    Spain: 70
    Country: Number of subjects enrolled
    Czech Republic: 139
    Worldwide total number of subjects
    221
    EEA total number of subjects
    221
    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)
    195
    From 65 to 84 years
    24
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient was enrolled on 17-Feb-2017 (FPFV) and last patient on 08-Nov-2017 (LPFV). The total number of patients randomised was 222 patients however 1 patient was randomised by error since he/she was still on a wash-out period and was therefore not eligible to be included and to receive study IMP. No data was collected for this patient.

    Pre-assignment
    Screening details
    		 Patients aged >=18 years who were diagnosed with idiopathic CAF that was unresponsive to previous therapy,who were able to comply with the study protocol as per investigator criteria, who did not meet any exclusion criterion and who or his/her representative/witness(as per applicable law) signed and dated the study informed consent were included.

    Period 1
    Period 1 title
    Treatment 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
    		 Group I
    Arm description
    		 2% DTZ cutaneous paste
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diltiazem hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous paste
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The diltiazem hydrochloride paste was presented as a 30 g tube containing the active substance at a 2% concentration (2% DTZ), for cutaneous use. The 2% DTZ paste was administered to deliver a total daily dose of 16 mg (approximately 8 mg b.i.d.) divided into two administrations (separated by approximately 12 hours).

    Arm title
    		 Group II
    Arm description
    		 2% DTZ cutaneous paste placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Diltiazem hydrochloride placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous paste
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The diltiazem hydrochloride placebo paste was presented as a 30 g tube for cutaneous use. The 2% DTZ placebo paste was administered to deliver a total daily dose of 16 mg (approximately 8 mg b.i.d.) divided into two administrations (separated by approximately 12 hours).

    Number of subjects in period 1
    		Group I Group II
    Started
    106
    115
    Completed
    81
    92
    Not completed
    25
    23
         Consent withdrawn by subject
    6
    7
         Adverse event, non-fatal
    5
    5
         Changes in concomitant medication
    3
    1
         Lost to follow-up
    5
    1
         Protocol deviation
    6
    9
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group I
    Arm description
    		 2% DTZ cutaneous paste
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diltiazem hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous paste
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The diltiazem hydrochloride paste was presented as a 30 g tube containing the active substance at a 2% concentration (2% DTZ), for cutaneous use. The 2% DTZ paste was administered to deliver a total daily dose of 16 mg (approximately 8 mg b.i.d.) divided into two administrations (separated by approximately 12 hours).

    Arm title
    		 Group II
    Arm description
    		 2% DTZ cutaneous paste placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Diltiazem hydrochloride placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous paste
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The diltiazem hydrochloride placebo paste was presented as a 30 g tube for cutaneous use. The 2% DTZ placebo paste was administered to deliver a total daily dose of 16 mg (approximately 8 mg b.i.d.) divided into two administrations (separated by approximately 12 hours).

    Number of subjects in period 2 [1]
    		Group I Group II
    Started
    56
    61
    Completed
    53
    57
    Not completed
    3
    4
         Lost to follow-up
    1
    3
         Protocol deviation
    2
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only if a patient reached chronic anal fissure (CAF) cure within the treatment period, the patient was followed for 24 weeks in order to evaluate CAF relapse. Patients who did not achieve cure during the 12 weeks of treatment period were discontinued from the study. In summary, the subsequent period (Period 2) was carried out exclusively in patients that reached clinical cure.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 2% DTZ cutaneous paste

    Reporting group title
    Group II
    Reporting group description
    		 2% DTZ cutaneous paste placebo

    Reporting group values
    		 Group I Group II Total
    Number of subjects
    		 106 115 221
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 90 105 195
        From 65-84 years
    		 14 10 24
        85 years and over
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.90 ( 14.82 ) 46.18 ( 12.52 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 51 95
        Male
    		 62 64 126
    Smoking habits
    Units: Subjects
        Yes
    		 8 17 25
        No
    		 88 88 176
        Ex-smoker
    		 9 9 18
        NP
    		 1 1 2
    Drinking habits
    Units: Subjects
        Yes
    		 22 27 49
        No
    		 83 87 170
        NP
    		 1 1 2
    Relevant medical history
    Units: Subjects
        Yes
    		 21 14 35
        No
    		 85 101 186
    Post-menopausal (only females)
    The post-menopausal variable/characteristic is only applicable to females.
    Units: Subjects
        Yes
    		 17 23 40
        No
    		 27 28 55
        NA
    		 62 64 126
    Sexual active (only females)
    The sexual active variable/characteristic is only applicable to females.
    Units: Subjects
        Yes
    		 24 24 48
        No
    		 20 25 45
        UNK
    		 0 2 2
        NA
    		 62 64 126
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 81.16 ( 14.36 ) 79.39 ( 14.86 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 171.89 ( 8.21 ) 171.57 ( 8.92 ) -

    End points

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    End points reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 2% DTZ cutaneous paste

    Reporting group title
    Group II
    Reporting group description
    		 2% DTZ cutaneous paste placebo
    Reporting group title
    Group I
    Reporting group description
    		 2% DTZ cutaneous paste

    Reporting group title
    Group II
    Reporting group description
    		 2% DTZ cutaneous paste placebo

    Primary: Chronic anal fissure cure within 12 weeks of treatment (Visit 4) (ITT population)

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    End point title
    		 Chronic anal fissure cure within 12 weeks of treatment (Visit 4) (ITT population)
    End point description
    End point type
    Primary
    End point timeframe
    Patients for which chronic anal fissure (CAF) cure was observed during the 12 week treatment period (cured on visit 2 or 3 or 4 - V2 or V3 or V4).
    End point values
    		 Group I Group II
    Number of subjects analysed
    103
    113
    Units: subjects
        Yes
    58
    65
        No
    45
    48
    Statistical analysis title
    		 Chronic Anal Fissure Cure
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.483
    Method
    		 Fisher exact
    Confidence interval

    Primary: Chronic anal fissure cure within 12 weeks of treatment (Visit 4) (PP population)

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    End point title
    		 Chronic anal fissure cure within 12 weeks of treatment (Visit 4) (PP population)
    End point description
    End point type
    Primary
    End point timeframe
    Patients for which chronic anal fissure (CAF) cure was observed during the 12 week treatment period (cured on visit 2 or 3 or 4 - V2 or V3 or V4).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    91
    Units: subjects
        Yes
    56
    60
        No
    26
    31
    Statistical analysis title
    		 Chronic Anal Fissure Cure (PP population)
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.434
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Chronic anal fissure cure within 8 weeks of treatment (Visit 3) (ITT population)

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    End point title
    		 Chronic anal fissure cure within 8 weeks of treatment (Visit 3) (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients for which cure of the chronic anal fissure (CAF) was observed until the 8th week of treatment (cured on visit 2 or 3 - V2 or V3).
    End point values
    		 Group I Group II
    Number of subjects analysed
    103
    113
    Units: subjects
        Yes
    17
    21
        No
    86
    92
    Statistical analysis title
    		 Chronic Anal Fissure Cure
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.413
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Chronic anal fissure cure within 8 weeks of treatment (Visit 3) (PP population)

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    End point title
    		 Chronic anal fissure cure within 8 weeks of treatment (Visit 3) (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients for which cure of the chronic anal fissure (CAF) was observed until the 8th week of treatment (cured on visit 2 or 3 - V2 or V3).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    91
    Units: subjects
        Yes
    16
    18
        No
    66
    73
    Statistical analysis title
    		 Chronic Anal Fissure Cure
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.559
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Chronic anal fissure cure after 4 weeks of treatment (Visit 2) (ITT population)

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    End point title
    		 Chronic anal fissure cure after 4 weeks of treatment (Visit 2) (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients for which cure of the chronic anal fissure (CAF) was observed until the 4th week of treatment (cured on visit 2 - V2 ).
    End point values
    		 Group I Group II
    Number of subjects analysed
    103
    113
    Units: subjects
        Yes
    6
    6
        No
    97
    107
    Statistical analysis title
    		 Chronic Anal Fissure Cure
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.551
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Chronic anal fissure cure after 4 weeks of treatment (Visit 2) (PP population)

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    End point title
    		 Chronic anal fissure cure after 4 weeks of treatment (Visit 2) (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients for which cure of the chronic anal fissure (CAF) was observed until the 4th week of treatment (cured on visit 2 - V2 ).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    91
    Units: subjects
        Yes
    6
    4
        No
    76
    87
    Statistical analysis title
    		 Chronic Anal Fissure Cure
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.31
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 12 weeks of treatment (Visit 4) (ITT population)

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    End point title
    		 Visual analogue scale for pain variation after 12 weeks of treatment (Visit 4) (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation vs. baseline assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 12th week of treatment (visit 4 – V4).
    End point values
    		 Group I Group II
    Number of subjects analysed
    100
    105
    Units: mm
        arithmetic mean (standard deviation)
    43.79 ( 29.60 )
    44.08 ( 30.25 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.527
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 12 weeks of treatment (Visit 4) (PP population)

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    End point title
    		 Visual analogue scale for pain variation after 12 weeks of treatment (Visit 4) (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation vs. baseline assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 12th week of treatment (visit 4 – V4).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    90
    Units: mm
        arithmetic mean (standard deviation)
    49.78 ( 26.46 )
    46.82 ( 28.43 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.241
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 8 weeks of treatment (Visit 3) (ITT population)

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    End point title
    		 Visual analogue scale for pain variation after 8 weeks of treatment (Visit 3) (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 8th week of treatment (visit 3 – V3).
    End point values
    		 Group I Group II
    Number of subjects analysed
    100
    105
    Units: mm
        arithmetic mean (standard deviation)
    38.52 ( 28.48 )
    38.29 ( 27.48 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.476
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 8 weeks of treatment (Visit 3) (PP population)

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    End point title
    		 Visual analogue scale for pain variation after 8 weeks of treatment (Visit 3) (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 8th week of treatment (visit 3 – V3).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    90
    Units: mm
        arithmetic mean (standard deviation)
    43.85 ( 26.62 )
    40.11 ( 25.61 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.174
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 4 weeks of treatment (Visit 2) (ITT population)

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    End point title
    		 Visual analogue scale for pain variation after 4 weeks of treatment (Visit 2) (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 4th week of treatment (visit 2 – V2).
    End point values
    		 Group I Group II
    Number of subjects analysed
    100
    105
    Units: mm
        arithmetic mean (standard deviation)
    27.81 ( 24.40 )
    25.35 ( 25.98 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.243
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Visual analogue scale for pain variation after 4 weeks of treatment (Visit 2) (PP population)

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    End point title
    		 Visual analogue scale for pain variation after 4 weeks of treatment (Visit 2) (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Symptomatic improvement of pain triggered by defecation assessed as variation in millimetres, using a visual analogue scale (VAS) for pain applied on the 4th week of treatment (visit 2 – V2).
    End point values
    		 Group I Group II
    Number of subjects analysed
    82
    90
    Units: mm
        arithmetic mean (standard deviation)
    31.07 ( 23.84 )
    25.38 ( 25.56 )
    Statistical analysis title
    		 Visual analogue scale for pain variation
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Chronic anal fissure relapse during the 24-week follow-up period (ITT population)

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    End point title
    		 Chronic anal fissure relapse during the 24-week follow-up period (ITT population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients with fissure relapse during a 24-week follow-up period after treatment withdrawal (final visit - VF).
    End point values
    		 Group I Group II
    Number of subjects analysed
    55
    57
    Units: subjects
        Yes
    7
    6
        No
    48
    51
    Statistical analysis title
    		 Chronic anal fissure relapse
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.472
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Chronic anal fissure relapse during the 24-week follow-up period (PP population)

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    End point title
    		 Chronic anal fissure relapse during the 24-week follow-up period (PP population)
    End point description
    End point type
    Secondary
    End point timeframe
    Patients with fissure relapse during a 24-week follow-up period after treatment withdrawal (final visit - VF).
    End point values
    		 Group I Group II
    Number of subjects analysed
    53
    55
    Units: subjects
        Yes
    7
    6
        No
    46
    49
    Statistical analysis title
    		 Chronic anal fissure relapse
    Comparison groups
    Group I v Group II
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.471
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The collection of adverse events started at the day of the first administration (V1) of the Investigational Medicinal Product and finished when the clinical trial was concluded (including the follow-up monitoring visits).
    Adverse event reporting additional description
    The adverse events information reported is only focused in the treatment period of the study since it is not possible to report the results from both phases separately due to platform restrictions. For any information about the follow-up analysis, the sponsor must be contacted.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 2% DTZ cutaneous paste

    Reporting group title
    Group II
    Reporting group description
    		 2% DTZ cutaneous paste placebo

    Serious adverse events
    		 Group I Group II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 105 (4.76%)
    2 / 115 (1.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament injury
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle operation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Perirectal abscess
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Group I Group II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 105 (30.48%)
    34 / 115 (29.57%)
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    3 / 105 (2.86%)
    4 / 115 (3.48%)
         occurrences all number
    3
    4
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 105 (0.00%)
    3 / 115 (2.61%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    3 / 105 (2.86%)
    8 / 115 (6.96%)
         occurrences all number
    3
    8
    Pain
         subjects affected / exposed
    3 / 105 (2.86%)
    2 / 115 (1.74%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Proctalgia
         subjects affected / exposed
    5 / 105 (4.76%)
    7 / 115 (6.09%)
         occurrences all number
    5
    7
    Anal fissure
         subjects affected / exposed
    1 / 105 (0.95%)
    4 / 115 (3.48%)
         occurrences all number
    1
    4
    Haemorrhoids
         subjects affected / exposed
    5 / 105 (4.76%)
    8 / 115 (6.96%)
         occurrences all number
    6
    8
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 105 (2.86%)
    5 / 115 (4.35%)
         occurrences all number
    3
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Aug 2017
    1) To ensure that all potential effects in pregnant women, foetus and newborns were captured for evaluation. 2) Addition of another rescue medication in order to relief the chronic anal fissure severe pain, since in some cases acetominophen is not enough.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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