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    Clinical Trial Results:
    The effects of COX-inhibiting drugs on skeletal muscle adaptations to resistance exercise in healthy adults.

    Summary
    EudraCT number
    		 2014-004872-47
    Trial protocol
    		 SE  
    Global end of trial date
    10 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2021
    First version publication date
    04 Apr 2021
    Other versions
    Summary report(s)
    		 Lilja et al. Acta Physiol

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NSAID2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02531451
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    17177, Stockholm, Sweden,
    Public contact
    Tommy Lundberg, Karolinska Institutet, Lab Medicine Dept, Clinical Physiology C1:82,Karolinska Univ Hosp, Huddinge, +46 858586771, tommy.lundberg@ki.se
    Scientific contact
    Tommy Lundberg, Karolinska Institutet, Lab Medicine Dept, Clinical Physiology C1:82,Karolinska Univ Hosp, Huddinge, +46 858586771, tommy.lundberg@ki.se
    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 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effects of Ibuprofen on skeletal muscle adaptations to resistance exercise (see study protocol).
    Protection of trial subjects
    Drug accountability, chief medical physician involvement, immediate reporting of adverse effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 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
    Sweden: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the Stockholm region between September 2015 to June 2016.

    Pre-assignment
    Screening details
    		 Recreationally active men and women aged 18–35 years were screened. From the 48 individuals who were assessed for eligibility, 31 were included in the final data analysis.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acetylsalicylic acid
    Arm description
    		 The control group received acetylsalicylic acid one dose per day (75 mg) in conjunction with their morning meal. One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    SUB12730MIG
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Acetylsalicylic acid was instructed to take one dose per day (75 mg) in conjunction with their morning meal.

    Arm title
    		 Ibuprofen
    Arm description
    		 The ibuprofen group was instructed to take three doses/day (~08:00, ~14:00 and ~20:00 h.) corresponding to the maximal over-the counter daily dose of 1200 mg (400 mg dose-1). One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    SUB08098MIG
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The ibuprofen group was instructed, orally and in writing, to take three doses/day (~08:00, ~14:00 and ~20:00 h.) corresponding to the maximal over-thec ounter daily dose of 1200 mg (400 mg dose-1).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The subjects were not blind to their treatment. The research personnel responsible for monitoring training sessions stayed blind for the drug assignment during the whole intervention, and the individual who performed the analysis was blind.
    Number of subjects in period 1
    		Acetylsalicylic acid Ibuprofen
    Started
    16
    15
    Completed
    16
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acetylsalicylic acid
    Reporting group description
    		 The control group received acetylsalicylic acid one dose per day (75 mg) in conjunction with their morning meal. One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.

    Reporting group title
    Ibuprofen
    Reporting group description
    		 The ibuprofen group was instructed to take three doses/day (~08:00, ~14:00 and ~20:00 h.) corresponding to the maximal over-the counter daily dose of 1200 mg (400 mg dose-1). One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.

    Reporting group values
    		 Acetylsalicylic acid Ibuprofen Total
    Number of subjects
    		 16 15 31
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 16 15 31
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26 ± 4 27 ± 5 -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 8 9 17
    Height
    Units: Cm
        arithmetic mean (standard deviation)
    		 174 ± 13 171 ± 9 -
    Body mass
    Units: Kg
        arithmetic mean (standard deviation)
    		 79 ± 22 77 ± 15 -
    m. Quadriceps volume Merged
    Units: (cm3)
        arithmetic mean (standard deviation)
    		 1026 ± 430 952 ± 272 -
    m. quadriceps volume WS leg
    WS = Weight stack training
    Units: cm3
        arithmetic mean (standard deviation)
    		 1011 ± 413 939 ± 258 -
    m. quadriceps volume FW leg
    FW = Flywheel ergometer
    Units: cm3
        arithmetic mean (standard deviation)
    		 1041 ± 449 964 ± 290 -
    m. quadriceps mean CSA Merged
    CSA = Muscle volume, mean cross-sectional area
    Units: cm2
        arithmetic mean (standard deviation)
    		 69 ± 22 71 ± 15 -
    m. quadriceps mean CSA WS leg
    CSA = Muscle volume, mean cross-sectional area. WS = Weight stack training.
    Units: cm2
        arithmetic mean (standard deviation)
    		 69 ± 21 71 ± 15 -
    m. quadriceps mean CSA FW leg
    CSA = Muscle volume, mean cross-sectional area. FW = Flywheel ergometer.
    Units: cm2
        arithmetic mean (standard deviation)
    		 70 ± 22 71 ± 16 -
    m. quadriceps signal intensity Merged
    MGV = Mean grey value.
    Units: MGV
        arithmetic mean (standard deviation)
    		 32.2 ± 7.1 33.5 ± 9.8 -
    m. quadriceps signal intensity WS leg
    WS = Weight stack training. MGV = Mean grey value.
    Units: MGV
        arithmetic mean (standard deviation)
    		 31.9 ± 7.9 32.4 ± 9.2 -
    m. quadriceps signal intensity FW leg
    FW = Flywheel ergometer. MGV = Mean grey value.
    Units: MGV
        arithmetic mean (standard deviation)
    		 32.6 ± 8.1 34.5 ± 11.2 -
    m. biceps femoris mean CSA Merged
    CSA = Muscle volume, mean cross-sectional area.
    Units: cm2
        arithmetic mean (standard deviation)
    		 12.5 ± 2.6 12.7 ± 2.5 -
    m. biceps femoris mean CSA WS leg
    CSA = Muscle volume, mean cross-sectional area. WS = Weight stack training
    Units: cm2
        arithmetic mean (standard deviation)
    		 12.6 ± 2.8 12.4 ± 2.5 -
    m. biceps femoris mean CSA FW leg
    CSA = Muscle volume, mean cross-sectional area. FW = Flywheel ergometer.
    Units: cm2
        arithmetic mean (standard deviation)
    		 12.3 ± 2.6 13.1 ± 2.9 -
    Estimated muscle water content
    Units: Percent
        arithmetic mean (standard deviation)
    		 74.8 ± 1.3 75.5 ± 1.5 -
    Protein concentration
    Units: ug mg-1 dry weight
        arithmetic mean (standard deviation)
    		 317 ± 111 307 ± 78 -
    Training-specific strength WS leg
    WS = Weight stack training.
    Units: Kg
        arithmetic mean (standard deviation)
    		 18.7 ± 8.4 18.7 ± 6.2 -
    Training-specific strength FW leg
    Units: Average peak power
        arithmetic mean (standard deviation)
    		 126 ± 54 124 ± 50 -

    End points

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    End points reporting groups
    Reporting group title
    Acetylsalicylic acid
    Reporting group description
    		 The control group received acetylsalicylic acid one dose per day (75 mg) in conjunction with their morning meal. One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.

    Reporting group title
    Ibuprofen
    Reporting group description
    		 The ibuprofen group was instructed to take three doses/day (~08:00, ~14:00 and ~20:00 h.) corresponding to the maximal over-the counter daily dose of 1200 mg (400 mg dose-1). One leg was assigned to perform training with maximal volitional work allowed in each repetition using a flywheel ergometer, while on the other leg the training volume was matched between groups using regular weight-stack training.

    Primary: Difference in Quadriceps volume Merged

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    End point title
    		 Difference in Quadriceps volume Merged
    End point description
    Difference in Quadriceps volume Merged from baseline to 8 weeks post resistance training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    7.5
    3.7
    Statistical analysis title
    		 Difference in Quadriceps volume Merged
    Statistical analysis description
    Difference in Quadriceps volume Merged from pre- to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps volume WS leg

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    End point title
    		 Difference in quadriceps volume WS leg
    End point description
    Difference in quadriceps volume WS leg from baseline to 8 weeks post resistance training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    8.1
    4.7
    Statistical analysis title
    		 Difference in quadriceps volume WS leg
    Statistical analysis description
    Difference in quadriceps volume WS leg from pre- to 8 weeks post training.
    Comparison groups
    Ibuprofen v Acetylsalicylic acid
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps volume FW leg

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    End point title
    		 Difference in quadriceps volume FW leg
    End point description
    Difference in quadriceps volume FW leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    6.9
    2.7
    Statistical analysis title
    		 Difference in quadriceps volume FW leg
    Statistical analysis description
    Difference in quadriceps volume FW leg from pre- to 8 weeks post training.
    Comparison groups
    Ibuprofen v Acetylsalicylic acid
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps mean CSA Merged

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    End point title
    		 Difference in quadriceps mean CSA Merged
    End point description
    Difference in quadriceps mean CSA Merged from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    7.5
    3.7
    Statistical analysis title
    		 Difference in quadriceps mean CSA Merged
    Statistical analysis description
    Difference in quadriceps mean CSA Merged from pre- to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps mean CSA WS leg

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    End point title
    		 Difference in quadriceps mean CSA WS leg
    End point description
    Difference in quadriceps mean CSA WS leg from baseline to 8 weeks post resistance training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    8.0
    4.7
    Statistical analysis title
    		 Difference in quadriceps mean CSA WS leg
    Statistical analysis description
    Difference in quadriceps mean CSA WS leg from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps mean CSA FW leg

    		 Close Top of page
    End point title
    		 Difference in quadriceps mean CSA FW leg
    End point description
    Difference in quadriceps mean CSA FW leg from baseline to 8 weeks post resistance training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    6.9
    3.1
    Statistical analysis title
    		 Difference in quadriceps mean CSA FW leg
    Statistical analysis description
    Difference in quadriceps mean CSA FW leg from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [6] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Primary: Difference in quadriceps signal intensity Merged

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    End point title
    		 Difference in quadriceps signal intensity Merged
    End point description
    Difference in quadriceps signal intensity Merged from baseline to 8 weeks post resistance training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    1.9
    0.9
    Statistical analysis title
    		 Difference quadriceps signal intensity Merged
    Statistical analysis description
    Difference quadriceps signal intensity Merged from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in quadriceps signal intensity WS leg

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    End point title
    		 Difference in quadriceps signal intensity WS leg
    End point description
    Difference in quadriceps signal intensity WS leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    1.9
    1.6
    Statistical analysis title
    		 Difference in quadriceps signal intensity WS leg
    Statistical analysis description
    Difference in quadriceps signal intensity WS leg from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [8] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in quadriceps signal intensity FW leg

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    End point title
    		 Difference in quadriceps signal intensity FW leg
    End point description
    Difference in quadriceps signal intensity FW leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    -4.1
    0.4
    Statistical analysis title
    		 Difference in quadriceps signal intensity FW leg
    Statistical analysis description
    Difference in quadriceps signal intensity FW leg from baseline to 8 weeks post training.
    Comparison groups
    Ibuprofen v Acetylsalicylic acid
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [9] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in biceps femoris mean CSA Merged

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    End point title
    		 Difference in biceps femoris mean CSA Merged
    End point description
    Difference in biceps femoris mean CSA Merged from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    -0.1
    -1.0
    Statistical analysis title
    		 Difference in biceps femoris mean CSA Merged
    Statistical analysis description
    Difference in biceps femoris mean CSA Merged from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [10] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in biceps femoris mean CSA WS leg

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    End point title
    		 Difference in biceps femoris mean CSA WS leg
    End point description
    Difference in biceps femoris mean CSA WS leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    -0.2
    -1.0
    Statistical analysis title
    		 Difference in biceps femoris mean CSA WS leg
    Statistical analysis description
    Difference in biceps femoris mean CSA WS leg from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [11] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in biceps femoris mean CSA FW leg

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    End point title
    		 Difference in biceps femoris mean CSA FW leg
    End point description
    Difference in biceps femoris mean CSA FW leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    0.1
    -1.2
    Statistical analysis title
    		 Difference in biceps femoris mean CSA FW leg
    Statistical analysis description
    Difference in biceps femoris mean CSA FW leg from baseline to 8 weeks post training.
    Comparison groups
    Ibuprofen v Acetylsalicylic acid
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [12] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in Estimated muscle water content

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    End point title
    		 Difference in Estimated muscle water content
    End point description
    Difference in Estimated muscle water content from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    0.6
    0.0
    Statistical analysis title
    		 Difference in Estimated muscle water content
    Statistical analysis description
    Difference in Estimated muscle water content from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [13] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in Protein concentration

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    End point title
    		 Difference in Protein concentration
    End point description
    Difference in Protein concentration from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    11
    11
    Statistical analysis title
    		 Difference in Protein concentration
    Statistical analysis description
    Difference in Protein concentration from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [14] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups.

    Primary: Difference in Training-specific strength WS leg

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    End point title
    		 Difference in Training-specific strength WS leg
    End point description
    Difference in Training-specific strength WS leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    26
    26
    Statistical analysis title
    		 Difference in Training-specific strength WS leg
    Statistical analysis description
    Difference in Training-specific strength WS leg from baseline to 8 weeks post training.
    Comparison groups
    Ibuprofen v Acetylsalicylic acid
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [15] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05).

    Primary: Difference in Training-specific strength FW leg

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    End point title
    		 Difference in Training-specific strength FW leg
    End point description
    Difference in Training-specific strength FW leg from baseline to 8 weeks post training.
    End point type
    Primary
    End point timeframe
    Baseline to 8 weeks post resistance training.
    End point values
    		 Acetylsalicylic acid Ibuprofen
    Number of subjects analysed
    16
    15
    Units: Percent
        number (not applicable)
    29
    20
    Statistical analysis title
    		 Difference in Training-specific strength FW leg
    Statistical analysis description
    Difference in Training-specific strength FW leg from baseline to 8 weeks post training.
    Comparison groups
    Acetylsalicylic acid v Ibuprofen
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [16]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [16] - Two-way ANOVAs with factors group (ASA vs. IBU) and time (PRE vs. POST) were used to compare training-induced changes in all dependent variables across the two groups. Main effect of time (P < 0.05). Group 9 time interaction (P < 0.05).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline and up to 8 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Adverse events NSAID
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    Acetylsalicylic acid
    Reporting group description
    		 -

    Reporting group title
    Ibuprofen
    Reporting group description
    		 -

    Serious adverse events
    		 Acetylsalicylic acid Ibuprofen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Acetylsalicylic acid Ibuprofen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 16 (56.25%)
    6 / 15 (40.00%)
    Gastrointestinal disorders
    Abdominal pain, heartburn
    Additional description: In total 15 adverse events. 4 were classified as moderate (1 IBU, 3 ASA), and 11 were classified as mild in severity (5 IBU, 6 ASA). 5 of the events (abdominal pain 3, heartburn 2) were possibly or likely related to the study drug (IBU 3, ASA 2).
         subjects affected / exposed
    9 / 16 (56.25%)
    6 / 15 (40.00%)
         occurrences all number
    9
    6

    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.
    A limitation of the current study was that we did not include a non-treated control group.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28834248
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