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    Clinical Trial Results:
    Multicentre, randomized, open-label study to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in the treatment of patients with chronic non-specific low back pain.

    Summary
    EudraCT number
    		 2022-001358-41
    Trial protocol
    		 DE   ES   CZ  
    Global end of trial date
    18 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2025
    First version publication date
    19 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VER-CLBP-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05610813
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertanical GmbH
    Sponsor organisation address
    Am Haag 14, Gräfelfing, Germany, 82166
    Public contact
    Dr Janin Grajcarek, Regulatory Affairs, +49 89 7879790-78, regulatory@vertanical.com
    Scientific contact
    Dr Janin Grajcarek, Regulatory Affairs, +49 89 7879790-78, regulatory@vertanical.com
    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
    18 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective was to prove a reduced risk of developing constipation under treatment with VER-01 compared to an opioid therapy at the end of Treatment Phase. Key secondary objective was to compare the efficacy of VER-01 to an opioid therapy in terms of pain reduction and reduction of low back pain interference with sleep. Other secondary objectives were to evaluate the safety and tolerability of VER-01 compared to an opioid therapy and to compare the efficacy of VER-01 to opioid therapy in terms of pain reduction.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 The following rescue medications could be used in the event of acute worsening of the Chronic Low Back Pain: Ibuprofen: maximum daily dose of up to 2,400 mg Paracetamol (when ibuprofen was contraindicated): maximum daily dose of up to 4,000 mg
    Evidence for comparator
    		 The comparative opioid therapy was selected on a patient-individual basis before randomisation at Visit 2 by the Investigator, considering comorbidities, concomitant medication, intolerances, previous experiences, and preferences of the patient. During the course of the study, the opioid therapy was gradually optimised to the individual patient needs (dose escalation, opioid rotation, or termination of therapy). This approach allowed to study the benefits of VER-01 compared to a patient-specific optimised opioid therapy taking into account all authorised opioids available on the market. Due to the large number of available opioids, dosage forms, and potencies, blinding was not possible, and an open-label design was chosen.
    Actual start date of recruitment
    10 Mar 2023
    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
    Poland: 55
    Country: Number of subjects enrolled
    Spain: 91
    Country: Number of subjects enrolled
    Czechia: 61
    Country: Number of subjects enrolled
    Germany: 168
    Worldwide total number of subjects
    375
    EEA total number of subjects
    375
    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)
    284
    From 65 to 84 years
    90
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Overall, 508 patients were screened. Out of these, 14 patients were re-screened, resulting in a total of 522 screenings. Of the 508 screened patients, 124 patients were screen failures. The remaining 384 patients were randomised to receive treatment with VER-01 (192 patients) or Opioid (192 patients).

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VER-01
    Arm description
    		 VER-01 is a herbal medicinal product consisting of the active pharmaceutical ingredient standardised oleoresin of Cannabis sativa L. folium cum flore, tetrahydrocannabinol (THC)-chemotype (cannabis leaves and flowers).
    Arm type
    		 Experimental

    Investigational medicinal product name
    VER-01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: Following patient-individual optimal dose finding in a 3-week Titration Phase, dosing twice per day (morning and evening) with a minimum daily dose of 1 dose unit (2.5 mg THC), a maximum daily dose of 13 dose units (32.5 mg), and a maximum single dose of 8 dose units (20 mg THC); in case of a daily dose of 1 dose unit, intake once daily in the evening. Mode of administration: Oral administration Duration of treatment: Approximately 27 weeks: a 3-week Titration Phase and a 24-week Treatment Phase.

    Arm title
    		 Opioid
    Arm description
    		 Opioid therapy was selected by the investigator individually for each patient at Visit 1 prior to randomisation to ensure that the outcome of the randomisation would not influence the opioid selection. The opioid selection was based on the country-specific standard of care and opioids provided for this study by the Sponsor.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Opioid
    Investigational medicinal product code
    Other name
    Possible opioids: Tilidine/Naloxone, Tramadol, Fentanyl, Oxycodone, Oxycodone / Naloxone, Hydromorphone, Morphine, Tapentadol, Buprenorphine
    Pharmaceutical forms
    Prolonged-release tablet, Transdermal patch
    Routes of administration
    Oral use, Transdermal use
    Dosage and administration details
    Dose: Following patient-individual optimal dose finding according to the SmPC of the marketed opioid chosen by the Investigator, daily dosage according to the SmPC of the used opioid therapy. Mode of administration: The route of administration (oral or transdermal) was chosen by the Investigator at Visit 1. Duration of treatment: Approximately 27 weeks: a 3-week Titration Phase and a 24-week Treatment Phase.

    Number of subjects in period 1
    		VER-01 Opioid
    Started
    189
    186
    Completed
    140
    126
    Not completed
    49
    60
         Consent withdrawn by subject
    6
    10
         Physician decision
    2
    1
         Adverse event, non-fatal
    24
    26
         Other
    1
    1
         Lost to follow-up
    1
    6
         Lack of efficacy
    4
    8
         Protocol deviation
    3
    -
         Withdrawal by subject
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VER-01
    Reporting group description
    		 VER-01 is a herbal medicinal product consisting of the active pharmaceutical ingredient standardised oleoresin of Cannabis sativa L. folium cum flore, tetrahydrocannabinol (THC)-chemotype (cannabis leaves and flowers).

    Reporting group title
    Opioid
    Reporting group description
    		 Opioid therapy was selected by the investigator individually for each patient at Visit 1 prior to randomisation to ensure that the outcome of the randomisation would not influence the opioid selection. The opioid selection was based on the country-specific standard of care and opioids provided for this study by the Sponsor.

    Reporting group values
    		 VER-01 Opioid Total
    Number of subjects
    		 189 186 375
    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)
    		 148 136 284
        From 65-84 years
    		 41 49 90
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.9 ( 13.6 ) 55.7 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 118 113 231
        Male
    		 71 73 144

    End points

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    End points reporting groups
    Reporting group title
    VER-01
    Reporting group description
    		 VER-01 is a herbal medicinal product consisting of the active pharmaceutical ingredient standardised oleoresin of Cannabis sativa L. folium cum flore, tetrahydrocannabinol (THC)-chemotype (cannabis leaves and flowers).

    Reporting group title
    Opioid
    Reporting group description
    		 Opioid therapy was selected by the investigator individually for each patient at Visit 1 prior to randomisation to ensure that the outcome of the randomisation would not influence the opioid selection. The opioid selection was based on the country-specific standard of care and opioids provided for this study by the Sponsor.

    Primary: Number of constipation responders - at Visit 9

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    End point title
    		 Number of constipation responders - at Visit 9
    End point description
    At Visit 9, a constipation responder is defined as a patient with: a change from baseline (Visit 2) in BFI total score of at least 15 points at Visit 9 and a BFI total score of more than 28.8 at Visit 9.
    End point type
    Primary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    154
    148
    Units: n
        number (not applicable)
    3
    19
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0003 [1]
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.5
    Notes
    [1] - Primary estimand: VER-01 vs. opioids: Effect estimate (SE) = -1.38 (0.51), p= 0.007; estimate = 0.25, 95% CI: [0.09; 0.69] Neuropathic vs. nociceptive: Effect estimate (SE) = -0.60 (0.49), p= 0.214

    Primary: Percentage of constipation responders - at Visit 9

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    End point title
    		 Percentage of constipation responders - at Visit 9 [2]
    End point description
    At Visit 9, a constipation responder is defined as a patient with: a change from baseline (Visit 2) in BFI total score of at least 15 points at Visit 9 and a BFI total score of more than 28.8 at Visit 9.
    End point type
    Primary
    End point timeframe
    At Visit 9
    Notes
    [2] - 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: The statistical analysis specified for the primary endpoint, “Number of constipation responders,” also applies to the “Percentage of constipation responders,” as the analyses are identical.
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    154
    148
    Units: Percentage of patients
        number (not applicable)
    1.9
    12.8
    No statistical analyses for this end point

    Secondary: Number of 30% / 50% pain responders

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    End point title
    		 Number of 30% / 50% pain responders
    End point description
    Number of 30% pain responders at Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    149 [3]
    141 [4]
    Units: responders
        30% pain responders, Week 15
    84
    72
        30% pain responders, Week 27
    86
    71
        50% pain responders, Week 15
    59
    47
        50% pain responders, Week 27
    56
    47
    Notes
    [3] - Week 27: 139
    [4] - Week 27: 119
    Statistical analysis title
    		 30% pain responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.37
    Statistical analysis title
    		 30% pain responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7174 [5]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [5] - Common risk difference: Estimate = 0.44, p = 0.430, 95% CI: [-0.07;0.15]
    Statistical analysis title
    		 50% pain responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.61
    Statistical analysis title
    		 50% pain responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.38

    Secondary: Percentage of 30% / 50% pain responders

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    End point title
    		 Percentage of 30% / 50% pain responders
    End point description
    Percentage of 30% pain responders at Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    149 [6]
    141 [7]
    Units: %
    number (not applicable)
        30% pain responders, Week 15
    56.4
    51.1
        30% pain responders, Week 27
    61.9
    59.7
        50% pain responders, Week 15
    39.6
    33.3
        50% pain responders, Week 27
    40.3
    39.5
    Notes
    [6] - Week 27: 139
    [7] - Week 27: 119
    No statistical analyses for this end point

    Secondary: Number of 30% / 50% pain responders - neuropathic pain subgroup

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    End point title
    		 Number of 30% / 50% pain responders - neuropathic pain subgroup
    End point description
    Number of 30% pain responders from Baseline to Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    46 [8]
    44 [9]
    Units: responders
        30% pain responders, Week 15
    26
    25
        30% pain responders, Week 27
    27
    26
        50% pain responders, Week 15
    24
    18
        50% pain responders, Week 27
    20
    18
    Notes
    [8] - Week 27: 45
    [9] - Week 27: 38
    Statistical analysis title
    		 30% pain responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.43
    Statistical analysis title
    		 30% pain responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4263 [10]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [10] - Common risk difference: Estimate = 0.01, p = 0.895, 95% CI: [-0.18; 0.21]
    Statistical analysis title
    		 50% pain responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2
    Statistical analysis title
    		 50% pain responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.5

    Secondary: Percentage of 30% / 50% pain responders - neuropathic pain subgroup

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    End point title
    		 Percentage of 30% / 50% pain responders - neuropathic pain subgroup
    End point description
    Percentage of 30% pain responders at Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    46 [11]
    44 [12]
    Units: %
    number (not applicable)
        30% pain responders, Week 15
    56.5
    56.8
        30% pain responders, Week 27
    60.0
    68.4
        50% pain responders, Week 15
    52.2
    40.9
        50% pain responders, Week 27
    44.4
    47.4
    Notes
    [11] - Week 27: 45
    [12] - Week 27: 38
    No statistical analyses for this end point

    Secondary: Number of 30% / 50% sleep quality responders

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    End point title
    		 Number of 30% / 50% sleep quality responders
    End point description
    Number of patients with a 30% / 50% improvement of the mean daily low back pain interference with sleep score evaluated on an 11-point NRS; Number of 30% pain responders at Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    150 [13]
    139 [14]
    Units: responders
        30% sleep quality responders, Week 15
    100
    88
        30% sleep quality responders, Week 27
    104
    84
        50% sleep quality responders, Week 15
    78
    59
        50% sleep quality responders, Week 27
    67
    61
    Notes
    [13] - Week 27: 139
    [14] - Week 27: 117
    Statistical analysis title
    		 30% sleep quality responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.25
    Statistical analysis title
    		 30% sleep quality responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.21
    Statistical analysis title
    		 50% sleep quality responders, Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.57
    Statistical analysis title
    		 50% sleep quality responders, Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.18

    Secondary: Percentage of 30% / 50% sleep quality responders

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    End point title
    		 Percentage of 30% / 50% sleep quality responders
    End point description
    Number of patients with a 30% / 50% improvement of the mean daily low back pain interference with sleep score evaluated on an 11-point NRS; Percentage of 30% pain responders at Week 27 = Key secondary endpoint
    End point type
    Secondary
    End point timeframe
    Baseline compared to Week 15 / 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    150 [15]
    139 [16]
    Units: %
    number (not applicable)
        30% sleep quality responders, Week 15
    66.7
    63.3
        30% sleep quality responders, Week 27
    74.8
    71.8
        50% sleep quality responders, Week 15
    52.0
    42.4
        50% sleep quality responders, Week 27
    48.2
    52.1
    Notes
    [15] - Week 27: 139
    [16] - Week 27: 117
    No statistical analyses for this end point

    Secondary: Number of constipation responders - at Visit 6

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    End point title
    		 Number of constipation responders - at Visit 6
    End point description
    A Visit 6, a constipation responder is defined as a patient with: a change from baseline (Visit 2) in BFI total score of at least 15 points at Visit 6 and a BFI total score of more than 28.8 at Visit 6.
    End point type
    Secondary
    End point timeframe
    At Visit 6 after 12 weeks treatment
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    164
    155
    Units: responders
    5
    18
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.69

    Secondary: Proportion of constipation responders - at Visit 6

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    End point title
    		 Proportion of constipation responders - at Visit 6
    End point description
    A Visit 6, a constipation responder is defined as a patient with: a change from baseline (Visit 2) in BFI total score of at least 15 points at Visit 6 and a BFI total score of more than 28.8 at Visit 6.
    End point type
    Secondary
    End point timeframe
    At Visit 6 after 12 weeks treatment
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    164
    155
    Units: %
        number (not applicable)
    3.0
    11.6
    No statistical analyses for this end point

    Secondary: Change from baseline in BFI subscores - at Visit 6 (Summary of ANCOVA)

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    End point title
    		 Change from baseline in BFI subscores - at Visit 6 (Summary of ANCOVA)
    End point description
    The BFI is an average of three patient-reported scores (each on a 0-100 scale) for the ease of defecation, the feeling of incomplete evacuation, and the personal judgment of constipation.
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    163
    152
    Units: Points
    least squares mean (standard error)
        Ease of defecation
    1.34 ( 1.11 )
    5.20 ( 1.15 )
        Feeling of incomplete bowel evacuation
    0.78 ( 0.99 )
    4.53 ( 1.03 )
        Personal judgement of constipation
    0.87 ( 1.01 )
    5.82 ( 1.04 )
    Statistical analysis title
    		 Ease of defecation
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.97
         upper limit
    		 -0.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.58
    Statistical analysis title
    		 Feeling of incomplete bowel evacuation
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.52
         upper limit
    		 -0.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.41
    Statistical analysis title
    		 Personal judgement of constipation
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.77
         upper limit
    		 -2.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.43

    Secondary: Change from baseline in BFI subscores - at Visit 9 (Summary of ANCOVA)

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    End point title
    		 Change from baseline in BFI subscores - at Visit 9 (Summary of ANCOVA)
    End point description
    The BFI is an average of three patient-reported scores (each on a 0-100 scale) for the ease of defecation, the feeling of incomplete evacuation, and the personal judgment of constipation.
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    153
    145
    Units: Points
    least squares mean (standard error)
        Ease of defecation
    -0.20 ( 1.18 )
    6.48 ( 1.67 )
        Feeling of incomplete bowel evacuation
    -0.01 ( 1.14 )
    6.27 ( 1.18 )
        Personal judgement of constipation
    0.50 ( 1.23 )
    7.23 ( 1.27 )
    Statistical analysis title
    		 Ease of defecation
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.98
         upper limit
    		 -3.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.67
    Statistical analysis title
    		 Feeling of incomplete bowel evacuation
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.48
         upper limit
    		 -3.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.63
    Statistical analysis title
    		 Personal judgement of constipation
    Comparison groups
    Opioid v VER-01
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.16
         upper limit
    		 -3.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.74

    Secondary: Change from baseline in BFI total score - at Visit 6 (Summary of ANCOVA)

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    End point title
    		 Change from baseline in BFI total score - at Visit 6 (Summary of ANCOVA)
    End point description
    The BFI is an average of three patient-reported scores (each on a 0-100 scale) for the ease of defecation, the feeling of incomplete evacuation, and the personal judgment of constipation.
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    163
    152
    Units: Points
        least squares mean (standard error)
    1.13 ( 0.95 )
    5.17 ( 0.98 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.69
         upper limit
    		 -1.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35

    Secondary: Change from baseline in BFI total score - at Visit 9 (Summary of ANCOVA)

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    End point title
    		 Change from baseline in BFI total score - at Visit 9 (Summary of ANCOVA)
    End point description
    The BFI is an average of three patient-reported scores (each on a 0-100 scale) for the ease of defecation, the feeling of incomplete evacuation, and the personal judgment of constipation.
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    153
    145
    Units: Points
        least squares mean (standard error)
    0.27 ( 1.09 )
    6.60 ( 1.12 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.38
         upper limit
    		 -3.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.54

    Secondary: Number of patients with intake of laxatives

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    End point title
    		 Number of patients with intake of laxatives
    End point description
    End point type
    Secondary
    End point timeframe
    From Visit 2 to Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    189
    186
    Units: number
    11
    32
    No statistical analyses for this end point

    Secondary: Percentage of patients with intake of laxatives

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    End point title
    		 Percentage of patients with intake of laxatives
    End point description
    End point type
    Secondary
    End point timeframe
    From Visit 2 to Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    189
    186
    Units: %
        number (not applicable)
    5.8
    17.2
    No statistical analyses for this end point

    Secondary: Number of days with intake of laxatives

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    End point title
    		 Number of days with intake of laxatives
    End point description
    End point type
    Secondary
    End point timeframe
    Between Visit 2 and Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    189
    186
    Units: Days
        arithmetic mean (standard deviation)
    57.2 ( 84.2 )
    49.2 ( 63.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean daily low back pain (11-point NRS)

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    End point title
    		 Change from baseline in mean daily low back pain (11-point NRS)
    End point description
    The numeric rating scale pain intensity ranges from 0 = no pain to 10 = worst pain imaginable.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 15 / Week 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    149 [17]
    141 [18]
    Units: Points
    arithmetic mean (standard error)
        Week 15
    -2.50 ( 2.00 )
    -2.26 ( 2.18 )
        Week 27
    -2.68 ( 1.96 )
    -2.73 ( 2.12 )
    Notes
    [17] - Week 27: 139
    [18] - Week 27: 119
    Statistical analysis title
    		 Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25

    Secondary: Change from baseline in mean daily low back pain (11-point NRS) - neuropathic pain subgroup

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    End point title
    		 Change from baseline in mean daily low back pain (11-point NRS) - neuropathic pain subgroup
    End point description
    The numeric rating scale pain intensity ranges from 0 = no pain to 10 = worst pain imaginable.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 15 / Week 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    46 [19]
    44 [20]
    Units: Points
    arithmetic mean (standard error)
        Week 15
    -2.94 ( 2.08 )
    -2.36 ( 2.31 )
        Week 27
    -3.05 ( 1.98 )
    -2.92 ( 2.22 )
    Notes
    [19] - Week 27: 45
    [20] - Week 27: 38
    Statistical analysis title
    		 Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46
    Statistical analysis title
    		 Week 27
    Comparison groups
    Opioid v VER-01
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46

    Secondary: Change from baseline pain interference with sleep (11-point NRS)

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    End point title
    		 Change from baseline pain interference with sleep (11-point NRS)
    End point description
    The numeric rating scale sleep quality ranges from 0 = no interference with sleep to 10 = very strong interference with sleep.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 15 / Week 27
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    150 [21]
    141 [22]
    Units: Points
    arithmetic mean (standard error)
        Week 15
    -2.57 ( 2.12 )
    -2.14 ( 2.14 )
        Week 27
    -2.72 ( 2.09 )
    -2.48 ( 2.06 )
    Notes
    [21] - Week 27: 139
    [22] - Week 27: 119
    Statistical analysis title
    		 Week 15
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Week 27
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: Change from baseline in EQ-5D-5L - at Visit 6

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    End point title
    		 Change from baseline in EQ-5D-5L - at Visit 6
    End point description
    EQ-ED-5L = European Quality of Life 5 Dimensions 5 Level
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    161
    152
    Units: Points
        arithmetic mean (standard deviation)
    0.14 ( 0.17 )
    0.15 ( 0.23 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Change from baseline in EQ-5D-5L - at Visit 9

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    End point title
    		 Change from baseline in EQ-5D-5L - at Visit 9
    End point description
    EQ-ED-5L = European Quality of Life 5 Dimensions 5 Level
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    151
    144
    Units: Points
        arithmetic mean (standard error)
    0.14 ( 0.19 )
    0.17 ( 0.22 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Number of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 6

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    End point title
    		 Number of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 6
    End point description
    The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient’s state of health. Minimal clinically relevant change for physical component score = improvement of more than 3.29 points from baseline. Minimal clinically relevant change for mental component score = improvement of more than 3.77 points from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    162
    152
    Units: number of patients
        Physical component summary
    117
    101
        Mental component summary
    51
    53
    Statistical analysis title
    		 Physical component summary
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.18
    Statistical analysis title
    		 Mental component summary
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.24

    Secondary: Percentage of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 6

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    End point title
    		 Percentage of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 6
    End point description
    The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient’s state of health. Minimal clinically relevant change for physical component score = improvement of more than 3.29 points from baseline. Minimal clinically relevant change for mental component score = improvement of more than 3.77 points from baseline.
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    162
    152
    Units: %
    number (not applicable)
        Physical component summary
    72.2
    66.4
        Mental component summary
    31.5
    34.9
    No statistical analyses for this end point

    Secondary: Number of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 9

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    End point title
    		 Number of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 9
    End point description
    The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient’s state of health. Minimal clinically relevant change for physical component score = improvement of more than 3.29 points from baseline. Minimal clinically relevant change for mental component score = improvement of more than 3.77 points from baseline.
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    144
    Units: number of patients
        Physical component summary
    112
    105
        Mental component summary
    47
    52
    Statistical analysis title
    		 Physical component summary
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.16
    Statistical analysis title
    		 Mental component summary
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.18

    Secondary: Percentage of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 9

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    End point title
    		 Percentage of patients with a minimal clinically relevant change in the SF-12 subscores - at Visit 9
    End point description
    The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient’s state of health. Minimal clinically relevant change for physical component score = improvement of more than 3.29 points from baseline. Minimal clinically relevant change for mental component score = improvement of more than 3.77 points from baseline.
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    144
    Units: %
    number (not applicable)
        Physical component summary
    73.7
    72.9
        Mental component summary
    30.9
    36.1
    No statistical analyses for this end point

    Secondary: Change from baseline in Roland Morris Disability Questionnaire - at Visit 6

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    End point title
    		 Change from baseline in Roland Morris Disability Questionnaire - at Visit 6
    End point description
    The Roland Morris Disability Questionnaire (RMDQ) is a self-administered, validated 24-items questionnaire to assess self-rated physical disability caused by low back pain. Each question marked as “is applicable” is scored with one point. The patient-individual total score is calculated as the sum of the scores and ranges from 0 = “no disability” to 24 = “severe disability”.
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    161
    152
    Units: Points
        arithmetic mean (standard deviation)
    -4.5 ( 4.6 )
    -3.7 ( 5.1 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.55

    Secondary: Change from baseline in Roland Morris Disability Questionnaire - at Visit 9

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    End point title
    		 Change from baseline in Roland Morris Disability Questionnaire - at Visit 9
    End point description
    The Roland Morris Disability Questionnaire (RMDQ) is a self-administered, validated 24-items questionnaire to assess self-rated physical disability caused by low back pain. Each question marked as “is applicable” is scored with one point. The patient-individual total score is calculated as the sum of the scores and ranges from 0 = “no disability” to 24 = “severe disability”.
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    144
    Units: Points
        arithmetic mean (standard deviation)
    -4.6 ( 4.8 )
    -4.3 ( 5.3 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.58

    Secondary: Number of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 6

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    End point title
    		 Number of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 6
    End point description
    The minimal clinically relevant change is based on the improvement of at least 30% in Roland Morris Disability Questionnaire total score compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline compared to Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    161
    150
    Units: number of patients
    112
    84
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    311
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.48

    Secondary: Percentage of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 6

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    End point title
    		 Percentage of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 6
    End point description
    The minimal clinically relevant change is based on the improvement of at least 30% in Roland Morris Disability Questionnaire total score compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline compared to Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    161
    84
    Units: %
        number (not applicable)
    69.6
    56.0
    No statistical analyses for this end point

    Secondary: Number of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 9

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    End point title
    		 Number of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 9
    End point description
    The minimal clinically relevant change is based on the improvement of at least 30% in Roland Morris Disability Questionnaire total score compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline compared to Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    143
    Units: number of patients
    100
    94
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.18

    Secondary: Percentage of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 9

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    End point title
    		 Percentage of patients with a minimal clinically relevant change in the Roland Morris Disability Questionnaire total score - at Visit 9
    End point description
    The minimal clinically relevant change is based on the improvement of at least 30% in Roland Morris Disability Questionnaire total score compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline compared to Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    143
    Units: %
        number (not applicable)
    65.8
    65.7
    No statistical analyses for this end point

    Secondary: Number of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 6

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    End point title
    		 Number of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 6
    End point description
    Derived binary scale for clinically relevant improvement of symptoms
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    160
    152
    Units: number of patients
    87
    74
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.39

    Secondary: Percentage of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 6

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    End point title
    		 Percentage of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 6
    End point description
    Derived binary scale for clinically relevant improvement of symptoms
    End point type
    Secondary
    End point timeframe
    At Visit 6
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    160
    152
    Units: %
        number (not applicable)
    54.4
    48.7
    No statistical analyses for this end point

    Secondary: Number of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 9

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    End point title
    		 Number of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 9
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    144
    Units: number of patients
    82
    75
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    Opioid v VER-01
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.28

    Secondary: Percentage of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 9

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    End point title
    		 Percentage of patients experiencing meaningful improvement of symptoms (PGIC) - at Visit 9
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 9
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    152
    144
    Units: %
        number (not applicable)
    53.9
    52.1
    No statistical analyses for this end point

    Secondary: Evaluation of withdrawal symptoms by Medication Withdrawal Questionnaire (SMWQ) scores - at Visit 10 or Follow-up Visit

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    End point title
    		 Evaluation of withdrawal symptoms by Medication Withdrawal Questionnaire (SMWQ) scores - at Visit 10 or Follow-up Visit
    End point description
    The SMWQ version 1 consists of 10 items, where each item is scored on a 5-point Likert scale ranging from 0 = “not at all”, 1 = “very little”, 2 = “a little”, 3 = “quite a lot”, to 4 = “very much”. A total score is calculated as the sum of the 10 items, ranging from 0 to 40. A higher total score means more withdrawal symptoms.
    End point type
    Secondary
    End point timeframe
    At Visit 10
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    143
    130
    Units: Points
        arithmetic mean (standard deviation)
    7.1 ( 6.2 )
    7.9 ( 6.7 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.78

    Secondary: Evaluation of withdrawal symptoms by Medication Withdrawal Questionnaire (SMWQ) scores - at Follow-up Visit

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    End point title
    		 Evaluation of withdrawal symptoms by Medication Withdrawal Questionnaire (SMWQ) scores - at Follow-up Visit
    End point description
    End point type
    Secondary
    End point timeframe
    At Follow-up (end of Wash-out Phase)
    End point values
    		 VER-01 Opioid
    Number of subjects analysed
    30
    42
    Units: Points
        arithmetic mean (standard deviation)
    9.2 ( 6.2 )
    8.4 ( 4.9 )
    Statistical analysis title
    		 VER-01 vs Opioid
    Comparison groups
    VER-01 v Opioid
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 3.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-Emergent Adverse Events (TEAEs) have been recorded continuously from the first test product intake until the end of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    VER-01
    Reporting group description
    		 -

    Reporting group title
    Opioid
    Reporting group description
    		 -

    Serious adverse events
    		 VER-01 Opioid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 189 (4.76%)
    8 / 186 (4.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Escherichia test positive
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (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
    Procedural pain
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal ischaemia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (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
    Osteoarthritis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VER-01 Opioid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    138 / 189 (73.02%)
    137 / 186 (73.66%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    42 / 189 (22.22%)
    21 / 186 (11.29%)
         occurrences all number
    55
    25
    Headache
         subjects affected / exposed
    22 / 189 (11.64%)
    27 / 186 (14.52%)
         occurrences all number
    31
    43
    Somnolence
         subjects affected / exposed
    12 / 189 (6.35%)
    12 / 186 (6.45%)
         occurrences all number
    15
    12
    Disturbance in attention
         subjects affected / exposed
    12 / 189 (6.35%)
    2 / 186 (1.08%)
         occurrences all number
    13
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 189 (6.35%)
    17 / 186 (9.14%)
         occurrences all number
    13
    22
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    29 / 189 (15.34%)
    13 / 186 (6.99%)
         occurrences all number
    44
    15
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    21 / 189 (11.11%)
    5 / 186 (2.69%)
         occurrences all number
    26
    5
    Nausea
         subjects affected / exposed
    18 / 189 (9.52%)
    25 / 186 (13.44%)
         occurrences all number
    27
    27
    Constipation
         subjects affected / exposed
    13 / 189 (6.88%)
    43 / 186 (23.12%)
         occurrences all number
    16
    60
    Diarrhoea
         subjects affected / exposed
    9 / 189 (4.76%)
    12 / 186 (6.45%)
         occurrences all number
    13
    14
    Vomiting
         subjects affected / exposed
    4 / 189 (2.12%)
    11 / 186 (5.91%)
         occurrences all number
    4
    13
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    10 / 189 (5.29%)
    11 / 186 (5.91%)
         occurrences all number
    13
    17
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    24 / 189 (12.70%)
    19 / 186 (10.22%)
         occurrences all number
    31
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2023
    Adaptation of layout according to form number CT008-03, Removal of signature for Medical Expert, Adaptation of PI signature page according to form number CT008-03, Clarification of pain group “NO” as “NO/Unclear”, Clarification of early study intervention discontinuation in 1.2 Study Scheme, Change of visit window of Visit 1 to 14 (-3) days, Separation of dispensing of opioids and VER-01 as well as of assessment of dosing of concomitant analgetic medication and study intervention in SoA, Clarification that nicotine abuse is not relevant for exclusion criterion 1, Clarification that rescue medication can be taken during Run-in Phase for exclusion criterion 12 and randomisation criterion 6, Exception for patients who discontinue study intervention before Visit 6 regarding valuation of treatment response and eligibility to continue treatment, Clarification of requirements for previous analgesic treatment including clarification of analgesic treatments listed in Table 4, and on prohibited analgesic treatment during the study, Instruction that patients experiencing withdrawal symptoms may receive study intervention outside SoA-specified timepoints, Definition that an AE is any medical event for patients during a clinical study, Correction of spelling mistakes and semantics, capital and lower case, usage of treatment a study intervention

    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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