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    Clinical Trial Results:
    Analgetic effect of perioperative klorzoxazon at total hip or knee arthroplasty

    Summary
    EudraCT number
    		 2015-001214-10
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jul 2020
    First version publication date
    18 Jul 2020
    Other versions
    Summary report(s)
    		 Protokol: Analgetisk effekt af perioperativ Chlorzoxazone ved Total hip- and knee surgery
    Investigating the Effect of Perioperative Chlorzoxazone

    Trial information

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    Trial identification
    Sponsor protocol code
    AAUH-01-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aalborg University Hospital, Farsø
    Sponsor organisation address
    Højgaardsvej 11, Farsø, Denmark, 9640
    Public contact
    Michael Ulrich, Ortopædkirurgisk forskningsenhed, michael.ulrich@rn.dk
    Scientific contact
    Michael Ulrich, Ortopædkirurgisk forskningsenhed, michael.ulrich@rn.dk
    Sponsor organisation name
    Ortopædkirurisk forsknings enhed, Aalborg Universitetshospital
    Sponsor organisation address
    højgaardsvej 11, Farsø, Denmark, 9640
    Public contact
    Michael Ulrich, Ortopædkirurgisk forskningsenhed, Aalborg universitetshospital, 45 51882306, michael.ulrich@rn.dk
    Scientific contact
    Michael Ulrich, Ortopædkirurgisk forskningsenhed, Aalborg universitetshospital, 45 51882306, michael.ulrich@rn.dk
    Sponsor organisation name
    Aalborg University Hospital, Farsø
    Sponsor organisation address
    Højggardsvej 11, Farsø, Denmark, 9640 Farsø
    Public contact
    Mogens Laursen, Aalborg University Hospital, Farsø, 45 20946846 , mola@rn.dk
    Scientific contact
    Mogens Laursen, Aalborg University Hospital, Farsø, 45 20946846 , mola@rn.dk
    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
    29 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigate the effect of perioperative treatment with klorzoxazon compared to placebo. Out of need of suplementary analgentics and expierence of pain after incertion of hip or knee arthroplasty
    Protection of trial subjects
    With any discomfort patient was treated with all necessary means and measures
    Background therapy
    		 Morphine, ibumetin, celecoxib, dulculax, pantoprazole, cefuroxime, xarelto, cyclonova, pamol
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 393
    Worldwide total number of subjects
    393
    EEA total number of subjects
    393
    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)
    129
    From 65 to 84 years
    258
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Inclusion criteria: Set to primary, optional, one-sided THA or TKA. 18 years and over Pt. has normal cognitive and linguistic functioning Pt. has given his oral informed consent

    Pre-assignment
    Screening details
    		 Exclusion criteria: Taking one or more of the following medications in the period from 4 weeks before OP to OP: Gapentins, Glucocorticoid, Opioids with daily consumption, Anxiolytics, Anti-epileptics. Alcohol abuse Current malignant disorder BMI greater than 40 Disease-affecting central or peripheral Allergy to Chlorzoxazone. Liver disease

    Pre-assignment period milestones
    Number of subjects started
    		 393
    Number of subjects completed
    		 393

    Period 1
    Period 1 title
    overall trail (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gr. 1 THA active Chlorzoxazone
    Arm description
    		 First 7 days from surgery day, patient receive: Gr. 1 THA: 8 AM: 250 mg Klorzoxazone, 4 PM: 250 mg Klorzoxazone, 22 PM: 250 mg Klorzoxazone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    klorzoazone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tbl x 3/day in 7 days

    Arm title
    		 Gr. 2 THA Look a like placebo
    Arm description
    		 First 7 days from surgery day patients received: Gr. 2 THA: 8 AM: Placebo, 4 PM: Placebo, 22 PM: Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Klorzoazon placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tbl. x 3/day in 7 days

    Arm title
    		 Gr. 3 TKA Active Chlorzoxazone
    Arm description
    		 First 7 days from surgery day patients received Gr. 3 TKA: 8 AM: 250 mg Klorzoxazone, 4 PM: 250 mg Klorzoxazone, 22 PM: 250 mg Klorzoxazone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Klorzoxazon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tbl x 3/day in 7 days

    Arm title
    		 Gr. 4: TKA placebo
    Arm description
    		 In 7 days from from surgery day patients received Gr. 4 TKA: 8 AM: Placebo, 4 PM: Placebo, 10 PM: Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    kalk
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet 3 times a day in 7 days

    Number of subjects in period 1
    		Gr. 1 THA active Chlorzoxazone Gr. 2 THA Look a like placebo Gr. 3 TKA Active Chlorzoxazone Gr. 4: TKA placebo
    Started
    97
    98
    100
    98
    Completed
    95
    96
    98
    91
    Not completed
    2
    2
    2
    7
         Physician decision
    -
    2
    2
    4
         Consent withdrawn by subject
    -
    -
    -
    2
         Adverse event, non-fatal
    2
    -
    -
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trail
    Reporting group description
    		 -

    Reporting group values
    		 overall trail Total
    Number of subjects
    		 393 393
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 129 129
        From 65-84 years
    		 258 258
        85 years and over
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.97 ± 25 -
    Gender categorical
    males and females, adults (18-100 years)
    Units: Subjects
        Female
    		 184 184
        Male
    		 209 209
    Subject analysis sets

    Subject analysis set title
    age
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Only adults are included in this study. There are no comparisons among age

    Subject analysis sets values
    		 age
    Number of subjects
    393
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    129
        From 65-84 years
    258
        85 years and over
    6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.97 ± 25
    Gender categorical
    males and females, adults (18-100 years)
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Gr. 1 THA active Chlorzoxazone
    Reporting group description
    		 First 7 days from surgery day, patient receive: Gr. 1 THA: 8 AM: 250 mg Klorzoxazone, 4 PM: 250 mg Klorzoxazone, 22 PM: 250 mg Klorzoxazone

    Reporting group title
    Gr. 2 THA Look a like placebo
    Reporting group description
    		 First 7 days from surgery day patients received: Gr. 2 THA: 8 AM: Placebo, 4 PM: Placebo, 22 PM: Placebo

    Reporting group title
    Gr. 3 TKA Active Chlorzoxazone
    Reporting group description
    		 First 7 days from surgery day patients received Gr. 3 TKA: 8 AM: 250 mg Klorzoxazone, 4 PM: 250 mg Klorzoxazone, 22 PM: 250 mg Klorzoxazone

    Reporting group title
    Gr. 4: TKA placebo
    Reporting group description
    		 In 7 days from from surgery day patients received Gr. 4 TKA: 8 AM: Placebo, 4 PM: Placebo, 10 PM: Placebo

    Subject analysis set title
    age
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Only adults are included in this study. There are no comparisons among age

    Primary: Pain

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    End point title
    		 Pain [1]
    End point description
    Pain experienced before surgery was registred with all patients when they were resting and when they were active. After surgery experienced pain was registred twise a day in 14 days, at rest and in activity
    End point type
    Primary
    End point timeframe
    See chart 1 in the protokol
    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: We refer to the protocol on page 21
    End point values
    		 Gr. 1 THA active Chlorzoxazone Gr. 2 THA Look a like placebo Gr. 3 TKA Active Chlorzoxazone Gr. 4: TKA placebo
    Number of subjects analysed
    97
    98
    100
    98
    Units: 1-100
    97
    98
    100
    98
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    A SAE is recorded if it occurs within 7 days of the last project drug administration
    Adverse event reporting additional description
    In conclusion, patients have experienced the same side effects as we might expect after a hip or knee alloplasty surgery, whether they were given chlorzoxazone or placebo - There is no significant difference between the two groups. We do not have any additional data which detect side effects or add other details to the drug chlorzoxazone
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Arm: Gr. 4: TKA placebo
    Reporting group description
    		 -

    Reporting group title
    Arm: Gr. 3 TKA Active Chlorzoxazone
    Reporting group description
    		 -

    Reporting group title
    Arm: Gr. 1 THA active Chlorzoxazone
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: We refer to the article: Investigating the effect of Perioperative Chlorzoxazone on Acute Postoperative Pain After Total Hip and Knee Replacement Surgery
    Serious adverse events
    		 Arm: Gr. 4: TKA placebo Arm: Gr. 3 TKA Active Chlorzoxazone Arm: Gr. 1 THA active Chlorzoxazone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Yellow skin
    Additional description: the patient had misread the medication instructions and taken a double dose of acetaminophen for a day and a half. However, S-paracetamol was normal. The symptoms are estimated to come from a gallstone. Patient was hospitalized for 2 days
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Hypotennsion and general discomfort
    Additional description: Blood percentage drops after surgery. Starting point 9.1 mmol / l decreased to 4.8 mmol / l. Treated with blood transfusion
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical condition abnormal
    Additional description: Blood percentage drops after surgery. Starting point 8,5 mmol / l decreased to 5,0 mmol / l. Treated with blood transfusion
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
    Additional description: After premedication, epileptic seizures are triggered. The patient is not familiar with epilepsy
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Blood in stools
    Additional description: Bleeding from the rectum after toilet visits. Familiar with angiodysplasia after radiotherapy back in March 2015
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    blood in vomiting
    Additional description: NSAID is discontinued and the symptoms ceased.
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nausea, vomiting and Hypotension
    Additional description: Turned out patient had increased S-creatine. NSAID was discontinued
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 100 (2.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.78%
    Non-serious adverse events
    		 Arm: Gr. 4: TKA placebo Arm: Gr. 3 TKA Active Chlorzoxazone Arm: Gr. 1 THA active Chlorzoxazone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)

    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
    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.

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