Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An open label, single dose phase Ib/IIa study to determine the safety and clinical effects of intra-articular injections of low doses of Lopain (MTX-071) in patients with chronic osteoarthritic knee joint pain

    Summary
    EudraCT number
    		 2017-004049-26
    Trial protocol
    		 BE  
    Global end of trial date
    16 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2021
    First version publication date
    09 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MTX-071-P02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mestex AG
    Sponsor organisation address
    Klosterberg 11, Basel, Switzerland, CH-4051
    Public contact
    Grünenthal Trial Information Desk, Mestex AG, Clinical-Trials@grunenthal.com
    Scientific contact
    Grünenthal Trial Information Desk, Mestex AG, Clinical-Trials@grunenthal.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 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the safety and tolerability of intra-articular injections of low doses of MTX-071 based on the incidence, nature and severity of AES /SAEs potentially causally related with the study medication.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95) and with applicable local requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    21
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at two orthopedic clinics experienced in the treatment of osteoarthritis of the knee.

    Pre-assignment
    Screening details
    		 24 subjects were enrolled

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MTX-071 Group 1 - lido
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (5 ml lidocaine 2%, IA) premedication 15 minutes before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 2 - lido
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (5 ml lidocaine 2%, IA) premedication 15 minutes before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 3 - lido
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (5 ml lidocaine 2%, IA) premedication 15 minutes before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 4 - ropi
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (5 ml lidocaine 2%) premedication 15 minutes before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 5 - no LA
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    No local anaesthetics before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 6 - ropi cons
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (2 ml ropivacaine 1%, IA) within 1 minute before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 7 - ropi cons
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (2 ml ropivacaine 1%, IA) within 1 minute before MTX-071 IA administration single dose

    Arm title
    		 MTX-071 Group 8 - ropi cons
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anaesthetics (2 ml ropivacaine 1%, IA) within 1 minute before MTX-071 IA administration single dose

    Number of subjects in period 1
    		MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Started
    3
    3
    3
    3
    3
    3
    3
    3
    Completed
    3
    3
    3
    3
    3
    3
    3
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MTX-071 Group 1 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 2 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 3 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 4 - ropi
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - no LA
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 6 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 7 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 8 - ropi cons
    Reporting group description
    		 -

    Reporting group values
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons Total
    Number of subjects
    		 3 3 3 3 3 3 3 3 24
    Age categorical
    Units: Subjects
        Adults (45-75 years)
    		 3 3 3 3 3 3 3 3 24
    Age continuous
    Units: years
        median (full range (min-max))
    		 52.0 (45 to 75) 53.0 (49 to 63) 57.0 (45 to 69) 63.0 (45 to 67) 60.0 (59 to 62) 52.0 (48 to 59) 53.0 (53 to 65) 59.0 (47 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 3 1 1 1 2 1 2 2 13
        Male
    		 0 2 2 2 1 2 1 1 11

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MTX-071 Group 1 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 2 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 3 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 4 - ropi
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - no LA
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 6 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 7 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 8 - ropi cons
    Reporting group description
    		 -

    Primary: Treatment-emergent adverse events

    		 Close Top of page
    End point title
    		 Treatment-emergent adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first study drug administration up to last observation i.e. 6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive
    End point values
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    3
    3
    Units: Subjects
        At least one TEAE
    3
    2
    3
    3
    3
    2
    3
    3
        At least one serious TEAE
    0
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE leading to death
    0
    0
    0
    0
    0
    0
    0
    0
        At least one grade 1 TEAE as worst severity
    1
    1
    1
    2
    1
    1
    1
    1
        At least one grade 2 TEAE as worst severity
    1
    0
    2
    1
    2
    1
    2
    2
        At least one grade 3 TEAE as worst severity
    1
    1
    0
    0
    0
    0
    0
    0
        At least one grade 4 TEAE as worst severity
    0
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE drug discontinued temporarily
    0
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE drug discontinued permanently
    0
    0
    0
    0
    0
    0
    0
    0
        At least one treatment-related TEAE
    3
    2
    2
    2
    2
    1
    3
    3
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline - treated knee in motion last 2 days

    		 Close Top of page
    End point title
    		 VAS efficacy changes from baseline - treated knee in motion last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection
    End point values
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    3
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    -56.67 ± 35.921
    -30.67 ± 39.107
    -34.00 ± 36.715
    -37.50 ± 47.389
    -8.00 ± 24.269
    -45.67 ± 34.078
    -26.33 ± 23.288
    -31.33 ± 16.921
        Day 30
    -63.00 ± 17.692
    -33.00 ± 39.585
    -40.33 ± 28.589
    -42.00 ± 49.568
    -25.33 ± 11.590
    -45.00 ± 35.553
    -30.67 ± 18.930
    -41.67 ± 13.051
        Day 90
    -62.00 ± 28.583
    -21.33 ± 31.214
    -46.33 ± 16.503
    -53.33 ± 15.177
    -34.33 ± 15.885
    -41.33 ± 37.448
    -46.00 ± 4.243
    -51.00 ± 4.000
        Day 180
    -63.33 ± 25.325
    -35.33 ± 14.742
    -33.67 ± 27.025
    -40.00 ± 28.000
    -37.00 ± 13.856
    -49.33 ± 10.786
    -50.33 ± 23.159
    -35.33 ± 20.207
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline - treated knee in rest last 2 days

    		 Close Top of page
    End point title
    		 VAS efficacy changes from baseline - treated knee in rest last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    3
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    -48.33 ± 27.429
    -29.67 ± 9.074
    -18.00 ± 25.159
    -34.67 ± 41.041
    -8.33 ± 16.010
    -17.00 ± 26.963
    -18.33 ± 18.009
    -1.67 ± 7.767
        Day 30
    -54.33 ± 18.717
    -22.33 ± 18.556
    -32.33 ± 10.263
    -32.00 ± 36.428
    -12.67 ± 6.807
    -15.67 ± 28.219
    -14.33 ± 20.207
    -9.00 ± 14.107
        Day 90
    -55.67 ± 26.558
    -12.33 ± 15.373
    -30.00 ± 14.731
    -35.67 ± 40.129
    -13.33 ± 8.145
    -11.33 ± 43.004
    -35.00 ± 1.414
    -17.00 ± 7.211
        Day 180
    -55.67 ± 26.633
    -27.67 ± 11.060
    -16.33 ± 31.182
    -25.67 ± 23.692
    -18.33 ± 14.468
    -21.00 ± 22.068
    -33.33 ± 26.312
    -0.33 ± 22.811
    No statistical analyses for this end point

    Secondary: Changes in total WOMAC score versus baseline

    		 Close Top of page
    End point title
    		 Changes in total WOMAC score versus baseline
    End point description
    WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, subject-relevant symptoms for pain, stiffness and physical function in subjects with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Number of subjects analysed
    3
    3
    3
    3
    3
    3
    3
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    -34.7 ± 17.93
    -18.7 ± 11.24
    -24.0 ± 26.89
    -28.6 ± 10.71
    -15.0 ± 10.39
    -24.7 ± 30.24
    -12.0 ± 17.44
    -18.5 ± 3.54
        Day 30
    -47.3 ± 8.62
    -22.0 ± 15.87
    -30.7 ± 15.95
    -29.3 ± 9.45
    -21.0 ± 18.08
    1.0 ± 25.46
    -9.3 ± 19.09
    -35.00 ± 20.52
        Day 90
    -47.7 ± 23.86
    -14.7 ± 9.71
    -26.7 ± 17.47
    -26.1 ± 5.68
    -25.0 ± 18.38
    -14.0 ± 14.73
    -18.7 ± 11.24
    -39.3 ± 15.50
        Day 180
    -44.3 ± 23.46
    -24.3 ± 11.72
    -20.0 ± 7.21
    -13.0 ± 21.66
    -17.0 ± 7.00
    -3.3 ± 26.54
    -16.3 ± 9.45
    -27.0 ± 14.53
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration up to last observation i.e. 6 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    MTX-071 Group 1 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 2 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 3 - lido
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 4 - ropi
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - no LA
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 6 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 7 - ropi cons
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 8 - ropi cons
    Reporting group description
    		 -

    Serious adverse events
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MTX-071 Group 1 - lido MTX-071 Group 2 - lido MTX-071 Group 3 - lido MTX-071 Group 4 - ropi MTX-071 Group 5 - no LA MTX-071 Group 6 - ropi cons MTX-071 Group 7 - ropi cons MTX-071 Group 8 - ropi cons
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    Injury, poisoning and procedural complications
    Wasp sting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Vascular disorders
    Hematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    Low blood pressure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Follicular hyperplasia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Feeling of warmth
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Flu-like symptoms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Sweating
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Cervicobrachalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Knee pain
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
         occurrences all number
    1
    1
    1
    1
    1
    1
    1
    1
    Knee pressure
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Leg pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Rib contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Stiffness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Bladder infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    Flu
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2018
    - Addition up to two extra cohorts of 3 patients and extend the sample size from 18 to 24 patients maximum - Investigate the intra-articular administration of 2ml 1% ropivacaine immediately before MTX-071 administration (less than 1 min. interval, consecutive administration) through the same needle left in place for both administrations.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 01 04:17:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA