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    Clinical Trial Results:
    Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2014-004924-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P04500
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00552110
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration Number: MK-0887-105
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day (QD) in treating participants with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2007
    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
    United States: 707
    Worldwide total number of subjects
    707
    EEA total number of subjects
    0
    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)
    42
    Adults (18-64 years)
    651
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 1329 participants were screened for this study at 54 centers in the US.

    Pre-assignment
    Screening details
    		 707 participants were randomized to Combination1, Combination3, Mometasone, Oxymetazoline, or Placebo (All Randomized Population). The Intent-To-Treat (ITT) population included all randomized participants who had taken at least one dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Combination1
    Arm description
    		 Morning (AM): Mometasone Furoate nasal spray (MFNS) 2 sprays/nostril plus oxymetazoline nasal spray (OXY) 1 spray/nostril. Evening (PM): matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate nasal spray (MFNS)
    Investigational medicinal product code
    Other name
    Nasonex®, MK-0887, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    MFNS 50 μg/spray (2 sprays in each nostril) once daily for 15 days.

    Investigational medicinal product name
    Oxymetazoline Nasal Spray (OXY)
    Investigational medicinal product code
    Other name
    Afrin®, MK-3384, SCH 093840, Oxymetazoline
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    OXY (0.05%, 100 μL/spray), 1-3 sprays in each nostril (depending upon randomization) for 15 days.

    Investigational medicinal product name
    matching placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray to MFNS (2 or 3 sprays in each nostril) for 15 days depending upon randomization.

    Arm title
    		 Combination3
    Arm description
    		 AM: MFNS 2 sprays/nostril plus OXY 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate nasal spray (MFNS)
    Investigational medicinal product code
    Other name
    Nasonex®, MK-0887, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    MFNS 50 μg/spray (2 sprays in each nostril) once daily for 15 days.

    Investigational medicinal product name
    Oxymetazoline Nasal Spray (OXY)
    Investigational medicinal product code
    Other name
    Afrin®, MK-3384, SCH 093840, Oxymetazoline
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    OXY (0.05%, 100 μL/spray), 1-3 sprays in each nostril (depending upon randomization) for 15 days.

    Investigational medicinal product name
    matching placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray to MFNS (2 or 3 sprays in each nostril) for 15 days depending upon randomization.

    Arm title
    		 Mometasone
    Arm description
    		 AM: MFNS 2 sprays/nostril plus matching placebo to MFNS 1 spray/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone Furoate nasal spray (MFNS)
    Investigational medicinal product code
    Other name
    Nasonex®, MK-0887, SCH 032088
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    MFNS 50 μg/spray (2 sprays in each nostril) once daily for 15 days.

    Investigational medicinal product name
    matching placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray to MFNS (2 or 3 sprays in each nostril) for 15 days depending upon randomization.

    Arm title
    		 Oxymetazoline
    Arm description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus OXY 2 sprays/nostril. PM: OXY 2 sprays/nostril. Participants received treatment for 15 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    matching placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray to MFNS (2 or 3 sprays in each nostril) for 15 days depending upon randomization.

    Investigational medicinal product name
    Oxymetazoline Nasal Spray (OXY)
    Investigational medicinal product code
    Other name
    Afrin®, MK-3384, SCH 093840, Oxymetazoline
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    OXY (0.05%, 100 μL/spray), 1-3 sprays in each nostril (depending upon randomization) for 15 days.

    Arm title
    		 Placebo
    Arm description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus matching placebo to MFNS 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    matching placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray to MFNS (2 or 3 sprays in each nostril) for 15 days depending upon randomization.

    Number of subjects in period 1
    		Combination1 Combination3 Mometasone Oxymetazoline Placebo
    Started
    146
    139
    139
    141
    142
    Treated (Intention To Treat [ITT])
    145
    139
    139
    140
    142
    Completed
    142
    134
    137
    133
    133
    Not completed
    4
    5
    2
    8
    9
         Withdrawn per Sponsor
    -
    1
    -
    -
    1
         Consent withdrawn by subject
    -
    2
    -
    3
    2
         Serious or Life-Threatening AE
    -
    -
    1
    -
    -
         Increased Blood Pressure at Visit 2
    -
    -
    -
    1
    -
         Failed to Comply With Study Requirements
    1
    1
    1
    -
    1
         Nonserious Adverse Event (AE)
    1
    -
    -
    1
    -
         Use of Prohibited Medication
    1
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    1
    1
         Delay of Study due to Relabeling
    -
    -
    -
    1
    -
         Lack of efficacy
    1
    -
    -
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Combination1
    Reporting group description
    		 Morning (AM): Mometasone Furoate nasal spray (MFNS) 2 sprays/nostril plus oxymetazoline nasal spray (OXY) 1 spray/nostril. Evening (PM): matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Combination3
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus OXY 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Mometasone
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus matching placebo to MFNS 1 spray/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Oxymetazoline
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus OXY 2 sprays/nostril. PM: OXY 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Placebo
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus matching placebo to MFNS 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group values
    		 Combination1 Combination3 Mometasone Oxymetazoline Placebo Total
    Number of subjects
    		 146 139 139 141 142 707
    Age Categorical
    Data reported for all randomized participants.
    Units: participants
        <=18 years
    		 8 12 5 5 12 42
        Between 18 and 64 years
    		 136 124 132 132 127 651
        >=65 years
    		 2 3 2 4 3 14
    Gender, Male/Female
    Data reported for all randomized participants.
    Units: participants
        Female
    		 93 93 101 96 89 472
        Male
    		 53 46 38 45 53 235

    End points

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    End points reporting groups
    Reporting group title
    Combination1
    Reporting group description
    		 Morning (AM): Mometasone Furoate nasal spray (MFNS) 2 sprays/nostril plus oxymetazoline nasal spray (OXY) 1 spray/nostril. Evening (PM): matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Combination3
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus OXY 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Mometasone
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus matching placebo to MFNS 1 spray/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Oxymetazoline
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus OXY 2 sprays/nostril. PM: OXY 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Placebo
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus matching placebo to MFNS 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Primary: Change from baseline in AM/PM instantaneous total nasal symptom score (NOW TNSS) averaged over Days 1 to 15

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    End point title
    		 Change from baseline in AM/PM instantaneous total nasal symptom score (NOW TNSS) averaged over Days 1 to 15
    End point description
    Participants scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, the four individual symptom scores were summed to a TNSS (range 0-12), which was then averaged for a single score across the 15 day treatment period. The ITT population, including all randomized participants who had taken at least one dose of study drug, was used for analysis.
    End point type
    Primary
    End point timeframe
    Baseline and 15 days of treatment
    End point values
    		 Combination1 Combination3 Mometasone Oxymetazoline Placebo
    Number of subjects analysed
    145
    138
    139
    139
    140
    Units: units on a scale
        least squares mean (standard error)
    -3.29 ( 0.209 )
    -3.36 ( 0.216 )
    -2.97 ( 0.213 )
    -2.44 ( 0.215 )
    -1.9 ( 0.209 )
    Statistical analysis title
    		 NOW TNSS Days 1-15: Combination3 vs. Oxymetazoline
    Statistical analysis description
    Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.
    Comparison groups
    Combination3 v Oxymetazoline
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 -0.38
    Statistical analysis title
    		 NOW TNSS Days 1-15: Combination1 vs. Oxymetazoline
    Statistical analysis description
    Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily. Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points.
    Comparison groups
    Combination1 v Oxymetazoline
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.002 [2]
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 -0.33
    Notes
    [1] - Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score
    [2] - Multiplicity for multiple treatment comparisons was not adjusted.
    Statistical analysis title
    		 NOW TNSS Days 1-15: Mometasone vs. Placebo
    Statistical analysis description
    Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.
    Comparison groups
    Mometasone v Placebo
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 -0.53

    Primary: Standardized area under the curve from 0 to 4 hours [AUC(0-4 hr)] of the change from baseline to hour 4 on Day 1 in nasal congestion score

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    End point title
    		 Standardized area under the curve from 0 to 4 hours [AUC(0-4 hr)] of the change from baseline to hour 4 on Day 1 in nasal congestion score
    End point description
    Participants scored the nasal congestion/stuffiness symptom using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1. The ITT population, including all randomized participants who had taken at least one dose of study drug, was used for analysis.
    End point type
    Primary
    End point timeframe
    From Baseline to hour 4 on Day 1
    End point values
    		 Combination1 Combination3 Mometasone Oxymetazoline Placebo
    Number of subjects analysed
    144
    138
    139
    139
    140
    Units: units on a scale
        least squares mean (standard error)
    -0.8 ( 0.056 )
    -0.92 ( 0.057 )
    -0.63 ( 0.057 )
    -1.06 ( 0.057 )
    -0.57 ( 0.056 )
    Statistical analysis title
    		 AUC0-4 on Day 1: Combination1 vs. Mometasone
    Statistical analysis description
    Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.
    Comparison groups
    Combination1 v Mometasone
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.021 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 -0.03
    Notes
    [3] - ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score
    [4] - Multiplicity for multiple treatment comparisons was not adjusted.
    Statistical analysis title
    		 AUC0-4 on Day 1: Combination3 vs. Mometasone
    Statistical analysis description
    Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily
    Comparison groups
    Combination3 v Mometasone
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 -0.14
    Statistical analysis title
    		 AUC0-4 on Day 1: Oxymetazoline vs. Placebo
    Statistical analysis description
    Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo
    Comparison groups
    Oxymetazoline v Placebo
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.35

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Treatment Day 1 through 30 days post study completion/discontinuation (up to 52 days total)
    Adverse event reporting additional description
    The ITT population, which included all randomized participants who had taken ≥1 dose of study medication, was used for safety analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Combination1
    Reporting group description
    		 Morning (AM): Mometasone Furoate nasal spray (MFNS) 2 sprays/nostril plus oxymetazoline nasal spray (OXY) 1 spray/nostril. Evening (PM): matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Combination3
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus OXY 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Mometasone
    Reporting group description
    		 AM: MFNS 2 sprays/nostril plus matching placebo to MFNS 1 spray/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Oxymetazoline
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus OXY 2 sprays/nostril. PM: OXY 2 sprays/nostril. Participants received treatment for 15 days.

    Reporting group title
    Placebo
    Reporting group description
    		 AM: matching placebo to MFNS 2 sprays/nostril plus matching placebo to MFNS 3 sprays/nostril. PM: matching placebo to MFNS 2 sprays/nostril. Participants received treatment for 15 days.

    Serious adverse events
    		 Combination1 Combination3 Mometasone Oxymetazoline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 139 (0.00%)
    1 / 139 (0.72%)
    0 / 140 (0.00%)
    1 / 142 (0.70%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 139 (0.00%)
    0 / 139 (0.00%)
    0 / 140 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Haemorrhage
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 139 (0.00%)
    1 / 139 (0.72%)
    0 / 140 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Combination1 Combination3 Mometasone Oxymetazoline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 145 (4.83%)
    5 / 139 (3.60%)
    10 / 139 (7.19%)
    7 / 140 (5.00%)
    8 / 142 (5.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 145 (4.83%)
    5 / 139 (3.60%)
    10 / 139 (7.19%)
    7 / 140 (5.00%)
    8 / 142 (5.63%)
         occurrences all number
    9
    5
    11
    8
    8

    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.
    Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.
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