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    Clinical Trial Results:
    EFFECT OF THE ADMINISTRATION OF ALLOPURINOL ON THE PREVENTION OF MUSCLE MASS LOSS IN IMMOBILIZED SUBJECTS.

    Summary
    EudraCT number
    		 2011-003541-17
    Trial protocol
    		 ES  
    Global end of trial date
    31 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2022
    First version publication date
    12 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALMU_2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Sanitaria La Fe de Valencia
    Sponsor organisation address
    Avenida Fernando Abril Martorell, Torre 106 A 7planta, 46026 València, , Valencia, Spain,
    Public contact
    UREC, Instituto de Investigacion Sanitaria La Fe, 34 963862758, investigacion_clinica@iislafe.es
    Scientific contact
    UREC, Instituto de Investigacion Sanitaria La Fe, 34 963862758, investigacion_clinica@iislafe.es
    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
    30 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determining the effect of allopurinol administration on the prevention of loss of muscle mass in immobilized subjects. In this way we aim to determine the role of xanthine oxidase in free radical production in skeletal muscle during a period of immobilization
    Protection of trial subjects
    The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions. An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2011
    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
    Spain: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    53
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patient inclusion period is estimated at 1 year from the start of the study. Hospital Universitari i Politècnic La Fe Valencia.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 53
    Number of subjects completed

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients with grade II ankle sprain Alopurinol
    Arm description
    		 Patients with grade II ankle sprain
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ALOPURINOL
    Investigational medicinal product code
    M04AA01
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Allopurinol 300 mg / 24 hours orally. Therapeutic group: M04AA01 Administration way: Oral Dose: 300 mg / 24h

    Arm title
    		 Patients with grade II ankle sprain Non Alopurinol
    Arm description
    		 Patients with grade II ankle sprain
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Health patient with Alopurinol
    Arm description
    		 Health patient
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ALOPURINOL
    Investigational medicinal product code
    M04AA01
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Allopurinol 300 mg / 24 hours orally. Therapeutic group: M04AA01 Administration way: Oral Dose: 300 mg / 24h

    Arm title
    		 Health patient Non Alopurinol
    Arm description
    		 Health patient
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Patients with grade II ankle sprain Alopurinol Patients with grade II ankle sprain Non Alopurinol Health patient with Alopurinol Health patient Non Alopurinol
    Started
    18
    17
    5
    13
    Completed
    13
    12
    4
    13
    Not completed
    5
    5
    1
    0
         Lost to follow-up
    5
    5
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients with grade II ankle sprain Alopurinol
    Reporting group description
    		 Patients with grade II ankle sprain

    Reporting group title
    Patients with grade II ankle sprain Non Alopurinol
    Reporting group description
    		 Patients with grade II ankle sprain

    Reporting group title
    Health patient with Alopurinol
    Reporting group description
    		 Health patient

    Reporting group title
    Health patient Non Alopurinol
    Reporting group description
    		 Health patient

    Reporting group values
    		 Patients with grade II ankle sprain Alopurinol Patients with grade II ankle sprain Non Alopurinol Health patient with Alopurinol Health patient Non Alopurinol Total
    Number of subjects
    		 18 17 5 13 53
    Age categorical
    Range of age between 18-40 years
    Units: Subjects
        Adults 18 - 40 years
    		 13 12 4 13 42
        Not Recorded
    		 5 5 1 0 11
    Gender categorical
    Units: Subjects
        Male
    		 13 12 4 13 42
        Not recorded
    		 5 5 1 0 11

    End points

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    End points reporting groups
    Reporting group title
    Patients with grade II ankle sprain Alopurinol
    Reporting group description
    		 Patients with grade II ankle sprain

    Reporting group title
    Patients with grade II ankle sprain Non Alopurinol
    Reporting group description
    		 Patients with grade II ankle sprain

    Reporting group title
    Health patient with Alopurinol
    Reporting group description
    		 Health patient

    Reporting group title
    Health patient Non Alopurinol
    Reporting group description
    		 Health patient

    Primary: percentage of muscle loss

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    End point title
    		 percentage of muscle loss
    End point description
    End point type
    Primary
    End point timeframe
    Treatment will be administered during the 15-day immobilization period and medication will be discontinued.
    End point values
    		 Patients with grade II ankle sprain Alopurinol Patients with grade II ankle sprain Non Alopurinol Health patient with Alopurinol Health patient Non Alopurinol
    Number of subjects analysed
    13
    12
    4
    13
    Units: Change of volume
        number (not applicable)
    13
    12
    4
    13
    Statistical analysis title
    		 Control vs allopurinol
    Statistical analysis description
    All the results will be expressed as mean values ± standard deviation, indicating the number of observations in parentheses. The statistical treatment of the results obtained, when comparing control groups with groups treated with allopurinol, is performed using Student's t-test. Knowing the t value and the degrees of freedom, the value of the probability "p" that the differences between the measurements of two sets of values is statistically significant is acceed to be less than 0.05 or 0.01.
    Comparison groups
    Patients with grade II ankle sprain Non Alopurinol v Patients with grade II ankle sprain Alopurinol v Health patient with Alopurinol v Health patient Non Alopurinol
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - Quantifcation of the changes in soleus muscle CSA during lower leg immobilization with a posterior ankle splint

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator will report all SAEs immediately (within 24 hours) after becoming aware of the event. The report has to be communicated to the promoter. The initial report will be immediately followed by detailed written reports and reflected in the CRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: For this study, given its low level of risk, no adverse events have occurred.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2015
    protocol changes

    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.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29476130
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