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    Clinical Trial Results:
    A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 – S1).

    Summary
    EudraCT number
    		 2016-002642-23
    Trial protocol
    		 BE   PL   CZ  
    Global end of trial date
    09 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2022
    First version publication date
    01 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NVD-CLN01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03100032
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 UMIN: UMIN000026062
    Sponsors
    Sponsor organisation name
    Novadip Biosciences
    Sponsor organisation address
    Watson & Crick Hill, Rue Granbonpré 11, Mont-saint Guibert, Belgium, 1435
    Public contact
    Regulatory Affairs Manager, Novadip Biosciences, Helene.servais@novadip.com
    Scientific contact
    Clinical & Medical Manager, Novadip Biosciences, Dieter.frijns@novadip.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
    01 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety (local and systemic) of a specific surgical intervention with the use of NVD-001 (AEs, AESI, SAEs) in patients with symptomatic low-grade degenerative spondylolisthesis grade I or II undergoing surgery for spinal fusion of one vertebral segment (L1-S1).
    Protection of trial subjects
    Postoperatively, the patients underwent 5 FU visits to assess safety (AEs, AEs of special interest [AESI], SAEs), surgical characteristics (blood loss, duration of hospital stay) Additional product specific safety measures were performed: 1. Safety lab testing 2. Scan of implant region and Chest. -Signs of local toxicity of experimental product have been evaluated on CT and radiographic images by the local radiologist and the principal investigator as well as by the independent radiologist(s) and include:  Trabecular bone resorption  Intravertebral cystic changes  Soft tissue calcification/ossification  Peridiscal soft tissue swelling  Hyperostosis  Tumour growth -Signs of systemic toxicity have been evaluated on chest radiographs by the local radiologist and include appearance of calcification/ ossification on serial X-Rays in comparison with preoperative X-Rays.  Ectopic bone formation
    Background therapy
    		 Subjects in the control group will be treated with autologous cancellous bone harvested at the time of the spinal fusion surgery. As harvesting bone from the iliac crest is associated with a series of complications and morbidity, only bone chips collected during laminectomy are allowed. If insufficient volume is available to fill and surround the cage(s), DBM can be added (as per hospital protocol). The trade name and manufacturer name of the product as well as the volume used will be recorded in the eCRF. NOTE: patient numbers: 23 NVD-001 9 comparator SOC Age range: --> the system did not allow to complete the below data correctly in age breakdown 18-64: 25 >64: 8
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Czechia: 7
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 48 patients were screened by 7 principal investigators (7 centers) from 3 countries (Belgium, Czech Republic and Poland) between 01 February 2017 and 31 July 2018.Therefore, a total of 32 patients were included (01 February 2017 to 29 June 2018), randomized and treated either with NVD-001 (N=23; 71.9%) or SOC (N=9; 28.1%).

    Pre-assignment
    Screening details
    		 A total of 48 patients were screened by 7 principal investigators (7 centers) from 3 countries (Belgium, Czech Republic and Poland) between 01 February 2017 and 31 July 2018 . Eleven patients were considered as screen failures. Five patients dropped out from the study before surgery.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of Care (SOC)
    Arm description
    		 Subjects of the control group will be treated with autologous cancellous bone locally harvested during the same operation. At the Investigator’s discretion, one or two interbody PEEK cage(s) is/are to be filled with and surrounded by autologous locally harvested cancellous bone (laminectomy) before implantation. As harvesting bone from the iliac crest is associated with a series of complications and morbidity, only bone chips (spinous process/lamina) collected during laminectomy are allowed. If insufficient volume is available to fill and surround the cage(s), DBM can be added (as per hospital protocol). The trade name of the product and volume used will be recorded in the eCRF.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Autologous bone
    Investigational medicinal product code
    Autologous bone harvested from the patient
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Subjects of the control group will be treated with autologous cancellous bone harvested locally. One or two interbody PEEK cage(s) is/are to be filled and surrounded with autologous locally harvested cancellous bone (laminectomy). As harvesting bone from the iliac crest is associated with a series of complications and morbidity, only bone chips (spinous process/lamina) collected during laminectomy are allowed. In the SOC group, the quantity of harvested bone chips was 3.4 ± 1.9 cc. Harvesting of bone chips was laminae in 8 patients (88.9%) and spinous in 1 patient (11.1%) of the SOC group. DBM was used in one patient only (11.1%).

    Arm title
    		 NVD-001
    Arm description
    		 The investigational Advanced Therapy Medicinal Product NVD 001 is an autologous cellular therapy. The product is obtained after isolation of ASCs from a fat tissue sample obtained by a minimally invasive subcutaneous procedure (liposuction) in the abdominal region of the patient, and their differentiation in osteogenic cells with a proprietary quality controlled DBM into a 3D-bone implant. NVD 001 is characterized in view to obtain the same properties as a real bone, non-immunogenic, with a desirable handling and mechanical characteristics. In the current study, NVD 001 must be used exclusively in conjunction with an interbody somatic cage and bilateral pedicle screw fixation with connecting rods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NVD-001
    Investigational medicinal product code
    NVD-001
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    It is expected that 3 containers with NVD 001 will be available per patient for the surgical intervention. Information on IMP including the total volume IMP sent (in grams) and the total volume of unused IMP (in grams) was variable and has been provided before the implant surgery to the sites by the sponsor. This information will also provide an estimated volume of used IMP (in grams). In the NVD-001 group, the quantity of IMP sent on site was 19.6 ± 2.3 g, the quantity used was 5.7 ± 3.6 g and the quantity unused was 13.9 ± 3.4 g

    Number of subjects in period 1
    		Standard of Care (SOC) NVD-001
    Started
    9
    23
    Completed
    9
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Safety will be assessed by: • Collecting all adverse events for incidence, severity, relatedness, required action and outcome, up to 12 months post-surgery. • Collecting all SAEs up to 24 months post-surgery. • Collecting AESI up to 24 months post-surgery as part of local and systemic toxicity such as: Signs of local toxicity of experimental product will be evaluated on CT and radiographic images by the local radiologist and the principal investigator as well as by the independent radiologist(s) and include:  Trabecular bone resorption  Intravertebral cystic changes  Soft tissue calcification/ossification  Peridiscal soft tissue swelling  Hyperostosis  Tumour growth Signs of systemic toxicity will be evaluated on chest radiographs by the local radiologist and include appearance of calcification/ ossification on serial X-Rays in comparison with preoperative X-Rays.  Ectopic bone formation

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
        18+
    		 32 32
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.2 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 13 13
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.3 ± 4.4 -
    Subject analysis sets

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    A modified Intent-to-Treat (mITT) cohort consisting of all subjects having been included, randomized, treated with NVD-001 or Standard of Care (SOC) and for whom at least one safety assessment was available after surgery.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A per protocol (PP) cohort consisting of all subjects from the mITT for whom no major protocol deviations had been reported. Based on the observation that for some patients the implanted volume of NVD-001 was very low, one additional PP elimination criterion was added, that was not included into the protocol, as it was believed that patients with a NVD-001 volume/disk height ratio lower than 50% would have a significant impact in the NVD-001 efficacy outcomes and would not be representative for the bone healing capacity of NVD-001. The rationale is that the higher the residual disk height, the higher the NVD-001 volume should be to fill the residual interbody space, generating the required bone to graft contact surface.

    Subject analysis sets values
    		 mITT Per Protocol
    Number of subjects
    32
    20
    Age categorical
    Units: Subjects
        18+
    32
    20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.2 ± 11.4
    56.7 ± 10.8
    Gender categorical
    Units: Subjects
        Female
    19
    12
        Male
    13
    8
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.3 ± 4.4
    27.3 ± 4.3

    End points

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    End points reporting groups
    Reporting group title
    Standard of Care (SOC)
    Reporting group description
    		 Subjects of the control group will be treated with autologous cancellous bone locally harvested during the same operation. At the Investigator’s discretion, one or two interbody PEEK cage(s) is/are to be filled with and surrounded by autologous locally harvested cancellous bone (laminectomy) before implantation. As harvesting bone from the iliac crest is associated with a series of complications and morbidity, only bone chips (spinous process/lamina) collected during laminectomy are allowed. If insufficient volume is available to fill and surround the cage(s), DBM can be added (as per hospital protocol). The trade name of the product and volume used will be recorded in the eCRF.

    Reporting group title
    NVD-001
    Reporting group description
    		 The investigational Advanced Therapy Medicinal Product NVD 001 is an autologous cellular therapy. The product is obtained after isolation of ASCs from a fat tissue sample obtained by a minimally invasive subcutaneous procedure (liposuction) in the abdominal region of the patient, and their differentiation in osteogenic cells with a proprietary quality controlled DBM into a 3D-bone implant. NVD 001 is characterized in view to obtain the same properties as a real bone, non-immunogenic, with a desirable handling and mechanical characteristics. In the current study, NVD 001 must be used exclusively in conjunction with an interbody somatic cage and bilateral pedicle screw fixation with connecting rods.

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    A modified Intent-to-Treat (mITT) cohort consisting of all subjects having been included, randomized, treated with NVD-001 or Standard of Care (SOC) and for whom at least one safety assessment was available after surgery.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A per protocol (PP) cohort consisting of all subjects from the mITT for whom no major protocol deviations had been reported. Based on the observation that for some patients the implanted volume of NVD-001 was very low, one additional PP elimination criterion was added, that was not included into the protocol, as it was believed that patients with a NVD-001 volume/disk height ratio lower than 50% would have a significant impact in the NVD-001 efficacy outcomes and would not be representative for the bone healing capacity of NVD-001. The rationale is that the higher the residual disk height, the higher the NVD-001 volume should be to fill the residual interbody space, generating the required bone to graft contact surface.

    Primary: Safety

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    End point title
    		 Safety
    End point description
    All adverse events for incidence, severity, relatedness, required action and outcome, up to 12 months post-surgery. All SAEs up to 24 months post-surgery. All AESI up to 24 months post-surgery as part of local and systemic toxicity such as signs of local toxicity of experimental product will be evaluated on CT and radiographic images by the local radiologist and the principal investigator as well as by the independent radiologist(s) and include:  Trabecular bone resorption  Intravertebral cystic changes  Soft tissue calcification/ossification  Peridiscal soft tissue swelling  Hyperostosis  Tumour growth Signs of systemic toxicity will be evaluated on chest radiographs by the local radiologist and include appearance of calcification/ ossification on serial X-Rays in comparison with preoperative X-Rays.  Ectopic bone formation
    End point type
    Primary
    End point timeframe
    D0 till 24m post-grafting
    End point values
    		 Standard of Care (SOC) NVD-001 mITT
    Number of subjects analysed
    9 [1]
    23 [2]
    32 [3]
    Units: AE
        Treatment Emergent AE (TAE)
    22
    55
    77
        Mild TAE
    17
    40
    57
        Moderate TAE
    5
    12
    17
        Severe TAE
    0
    3
    3
        SAE
    1
    5
    6
        Surgical procedure related TAE
    13
    28
    41
        Bone Graft Related TAE
    0
    0
    0
        AE of Special Interest (AESI)
    0
    2
    2
    Notes
    [1] - SOC
    [2] - NVD-001
    [3] - All mITT patients
    Statistical analysis title
    		 Fisher’s exact tests
    Statistical analysis description
    The frequency of treatment-emergent AEs through Month 12 (for all types of AEs) and Month 24 (AESI, SAEs) will be summarised by treatment group. Treatment-emergent AEs are those AEs that started or were present but worsened after completion of surgery.
    Comparison groups
    NVD-001 v Standard of Care (SOC)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [4] - this is only descriptive without statistics

    Secondary: Average Pain (Brief pain Inventory questionnaire)

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    End point title
    		 Average Pain (Brief pain Inventory questionnaire)
    End point description
    The BPI-SF is a short, self-report or interview questionnaire, designed to assess the severity of pain and the impact of pain on daily functions. Four pain severity items (worst pain, least pain, average pain, and pain now) and seven pain interference items measuring the level of interference with a given function caused by pain (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) are rated on 0–10 scales. This endpoint focusses on average pain.
    End point type
    Secondary
    End point timeframe
    D0-M24
    End point values
    		 Standard of Care (SOC) NVD-001 Per Protocol
    Number of subjects analysed
    9
    23
    20
    Units: VAS Score
    arithmetic mean (standard deviation)
        V0
    5.2 ± 2.775
    4.07 ± 2.631
    1.67 ± 1.155
        V6 (12m)
    1.8 ± 1.304
    2.27 ± 2.374
    1.92 ± 2.397
        V8 (24m)
    1.67 ± 1.155
    1.92 ± 2.397
    1.87 ± 2.187
    No statistical analyses for this end point

    Secondary: Trabecular bone bridging score

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    End point title
    		 Trabecular bone bridging score
    End point description
    End point type
    Secondary
    End point timeframe
    6m and 24m post grafting surgery
    End point values
    		 Standard of Care (SOC) NVD-001 mITT Per Protocol
    Number of subjects analysed
    9 [5]
    23 [6]
    22 [7]
    15
    Units: % bridging
        6m - 0%
    0
    14
    14
    9
        6m - 1-25%
    1
    4
    4
    4
        6m - 26-50%
    1
    0
    0
    0
        6m - 51-75%
    4
    0
    0
    2
        6m - 76-99%
    3
    5
    5
    5
        6m - 100%
    0
    0
    0
    0
        12m - 0%
    0
    11
    11
    7
        12m - 1-25%
    0
    2
    2
    1
        12m - 26-50%
    0
    2
    2
    1
        12m 51-75%
    1
    2
    1
    1
        12m - 76-99%
    7
    12
    5
    8
        12m - 100%
    1
    2
    1
    1
    Notes
    [5] - 6m or 12m FU CT mITT
    [6] - 6m or 12m FU CT NVD-001 mITT
    [7] - mITT NVD001 vs PP NVD001
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening till 24 months post-Grafting Surgery
    Adverse event reporting additional description
    • Collecting all adverse events for incidence, severity, relatedness, required action and outcome, up to 12 months post-surgery. • Collecting all SAEs up to 24 months post-surgery. • Collecting AESI up to 24 months post-surgery as part of local and systemic toxicity
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Standard of Care (SOC)
    Reporting group description
    		 Subjects of the control group will be treated with autologous cancellous bone locally harvested during the same operation. At the Investigator’s discretion, one or two interbody PEEK cage(s) is/are to be filled with and surrounded by autologous locally harvested cancellous bone (laminectomy) before implantation.

    Reporting group title
    NVD-001
    Reporting group description
    		 The investigational Advanced Therapy Medicinal Product NVD 001 is an autologous cellular therapy. The product is obtained after isolation of ASCs from a fat tissue sample obtained by a minimally invasive subcutaneous procedure (liposuction) in the abdominal region of the patient, and their differentiation in osteogenic cells with a proprietary quality controlled DBM into a 3D-bone implant. NVD 001 is characterized in view to obtain the same properties as a real bone, non-immunogenic, with a desirable handling and mechanical characteristics. In the current study, NVD 001 must be used exclusively in conjunction with an interbody somatic cage and bilateral pedicle screw fixation with connecting rods.

    Serious adverse events
    		 Standard of Care (SOC) NVD-001
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 23 (13.04%)
         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)
    Breast cancer
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard of Care (SOC) NVD-001
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    10 / 23 (43.48%)
    Investigations
    Pseudomonas test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Blood potassium increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 23 (21.74%)
         occurrences all number
    2
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Red blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 23 (17.39%)
         occurrences all number
    2
    4
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Contusion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Dural Tear
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Post procedural haematoma
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Radicular pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Bone hypertrophy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Osteolysis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Impaired fasting glucose
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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