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    Clinical Trial Results:
    Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis

    Summary
    EudraCT number
    		 2017-002726-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2018
    First version publication date
    02 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-08-32
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00789555
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@novartis.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
    04 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2008
    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: 1260
    Worldwide total number of subjects
    1260
    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)
    146
    Adults (18-64 years)
    1086
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited and enrolled from 69 US study centers.

    Pre-assignment
    Screening details
    		 234 subjects were enrolled under protocol Version 1.0, then exited due to a revision in the study plan. A new cohort of 1026 subjects was enrolled in protocol Version 2.0, for a total enrollment of 1260 subjects.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PATANASE
    Arm description
    		 Two sprays in each nostril twice a day for up to 12 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olopatadine hydrochloride 0.6%
    Investigational medicinal product code
    Other name
    PATANASE®
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Olopatadine hydrochloride 0.6% nasal spray (PATANASE) Two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Arm title
    		 Patanase Vehicle, pH 3.7
    Arm description
    		 Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    Olopatadine nasal spray vehicle, pH 3.7
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Arm title
    		 Patanase Vehicle, pH 7.0
    Arm description
    		 Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    Olopatadine nasal spray vehicle, pH 7.0
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Number of subjects in period 1
    		PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Started
    421
    417
    422
    Completed
    262
    278
    263
    Not completed
    159
    139
    159
         Treatment failure
    11
    8
    12
         Adverse event, non-fatal
    17
    7
    10
         Protocol Amendment
    78
    76
    80
         Patient decision unnrelated to adv event
    38
    29
    26
         Protocol Violation
    6
    9
    13
         Lost to follow-up
    9
    10
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PATANASE
    Reporting group description
    		 Two sprays in each nostril twice a day for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 3.7
    Reporting group description
    		 Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 7.0
    Reporting group description
    		 Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Reporting group values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0 Total
    Number of subjects
    		 421 417 422 1260
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ± 14.5 36.2 ± 14.2 38.3 ± 14.6 -
    Gender categorical
    Units: Subjects
        Female
    		 251 260 278 789
        Male
    		 170 157 144 471

    End points

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    End points reporting groups
    Reporting group title
    PATANASE
    Reporting group description
    		 Two sprays in each nostril twice a day for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 3.7
    Reporting group description
    		 Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 7.0
    Reporting group description
    		 Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months

    Primary: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)

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    End point title
    		 Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
    End point description
    Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0), Exit (Month 12 or sooner)
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    386
    386
    381
    Units: Percentage of subjects
    number (not applicable)
        Anatomic Abnormalities
    0.8
    1.3
    0.3
        Bleeding
    0.8
    1.0
    2.6
        Infection
    0.3
    1.0
    0.0
        Possible Ulcerations
    0.5
    0.5
    1.6
    Statistical analysis title
    		 Clinically relevant change: Anatomic Abnormalities
    Comparison groups
    PATANASE v Patanase Vehicle, pH 3.7
    Number of subjects included in analysis
    772
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.7251
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - Chi-squared test of independence
    Statistical analysis title
    		 Clinically relevant change: Anatomic Abnormalities
    Comparison groups
    PATANASE v Patanase Vehicle, pH 7.0
    Number of subjects included in analysis
    767
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.6241
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [2] - Fisher's Exact test
    Statistical analysis title
    		 Clinically relevant change: Bleeding
    Comparison groups
    PATANASE v Patanase Vehicle, pH 3.7
    Number of subjects included in analysis
    772
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - Chi-squared test of independence
    Statistical analysis title
    		 Clinically relevant change: Bleeding
    Comparison groups
    PATANASE v Patanase Vehicle, pH 7.0
    Number of subjects included in analysis
    767
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.0475
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [4] - Fisher's Exact test
    Statistical analysis title
    		 Clinically relevant change: Infection
    Comparison groups
    PATANASE v Patanase Vehicle, pH 3.7
    Number of subjects included in analysis
    772
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.3734
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [5] - Chi-squared test of Independence
    Statistical analysis title
    		 Clinically relevant change: Infection
    Comparison groups
    PATANASE v Patanase Vehicle, pH 7.0
    Number of subjects included in analysis
    767
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [6] - Fisher's Exact test
    Statistical analysis title
    		 Clinically relevant change: Possible ulcerations
    Comparison groups
    PATANASE v Patanase Vehicle, pH 3.7
    Number of subjects included in analysis
    772
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [7] - Fisher's Exact test
    Statistical analysis title
    		 Clinically relevant change: Possible ul...
    Comparison groups
    PATANASE v Patanase Vehicle, pH 7.0
    Number of subjects included in analysis
    767
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.1749
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [8] - Chi-squared test of independence

    Primary: Self-Rated Relief Assessment at Day 30

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    End point title
    		 Self-Rated Relief Assessment at Day 30
    End point description
    Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief." This analysis population includes all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    328
    331
    330
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Self-Rated Relief Assessment at Day 30
    2.4 ± 0.9
    2.7 ± 1.0
    2.7 ± 0.9
    Statistical analysis title
    		 Mean response in Self-rated Relief Assessment
    Comparison groups
    Patanase Vehicle, pH 3.7 v PATANASE
    Number of subjects included in analysis
    659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)

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    End point title
    		 Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
    End point description
    Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes. Safety analysis set, minus any missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Exit (Month 12 or sooner)
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    416
    414
    418
    Units: Percentage of subjects
    number (not applicable)
        Decrease greater than 30 BPM
    0.0
    0.0
    0.0
        Decrease 21-30 BPM
    0.7
    1.2
    0.5
        Decrease 11-20 BPM
    7.5
    9.2
    6.2
        Decrease 1-10 BPM
    27.2
    30.4
    34.7
        No Change
    7.5
    6.5
    7.9
        Increase 1-10 BPM
    38.7
    38.9
    39.7
        Increase 11-20 BPM
    16.8
    9.9
    8.9
        Increase 21-30 BPM
    1.4
    3.6
    1.4
        Increase greater than 30 BPM
    0.2
    0.2
    0.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)

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    End point title
    		 Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
    End point description
    Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure. Safety analysis set, minus any missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Exit (Month 12 or sooner)
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    416
    413
    418
    Units: Percentage of subjects
    number (not applicable)
        Decrease greater than 30 mmHg
    0.5
    1.2
    0.5
        Decrease 21-30 mmHg
    1.0
    2.4
    2.4
        Decrease 11-20 mmHg
    11.8
    9.2
    10.0
        Decrease 1-10 mmHg
    35.3
    36.3
    35.4
        No change
    4.6
    5.3
    5.3
        Increase 1-10 mmHg
    35.1
    33.4
    34.4
        Increase 11-20 mmHg
    10.6
    10.2
    10.5
        Increase 21-30 mmHg
    1.2
    1.9
    1.2
        Increase greater than 30 mmHg
    0.0
    0.0
    0.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)

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    End point title
    		 Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
    End point description
    Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure. Safety analysis set, minus any missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Exit (Month 12 or sooner)
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    416
    413
    418
    Units: Percentage of subjects
    number (not applicable)
        Decrease greater than 30 mmHg
    0.0
    0.2
    0.2
        Decrease 21-30 mmHg
    0.7
    1.0
    0.5
        Decrease 11-20 mmHg
    8.7
    13.6
    11.5
        Decrease 1-10 mmHg
    44.5
    38.7
    42.6
        No change
    7.5
    6.1
    6.5
        Increase 1-10 mmHg
    33.2
    33.4
    33.7
        Increase 11-20 mmHg
    5.3
    6.5
    5.0
        Increase 21-30 mmHg
    0.2
    0.5
    0.0
        Increase greater than 30 mmHg
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)

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    End point title
    		 Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
    End point description
    Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. Safety analysis set, minus any missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Exit (Month 12 or sooner)
    End point values
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Number of subjects analysed
    404
    403
    392
    Units: Percentage of subjects
    number (not applicable)
        Head/EENT
    5.2
    4.2
    4.6
        Neck
    0.0
    0.7
    0.0
        Cardiovascular
    0.0
    0.5
    0.3
        Pulmonary
    0.7
    0.2
    0.3
        Abdomen
    0.0
    0.0
    0.3
        Skin and Extremities
    1.2
    0.5
    1.3
        Neurological
    0.7
    0.0
    0.0
        Lymph Nodes
    0.0
    0.2
    0.0
        Musculoskeletal
    0.0
    0.5
    0.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected for the duration of the study: 2 years, 1 month, 16 days. Adverse events were defined as any untoward (unfavorable and unintended) medical occurrence in a subject administered a test article.
    Adverse event reporting additional description
    Adverse events were collected after the first dose of study medication at Visit 1 and during each monthly on-therapy study visit through Visit 13 (or Early Exit). Safety Analysis Set was used for analysis. Only total subjects affected by non-serious AEs that occur at >5% are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    PATANASE
    Reporting group description
    		 Two sprays in each nostril twice a day for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 3.7
    Reporting group description
    		 Two sprays in each nostril twice a day for up to 12 months

    Reporting group title
    Patanase Vehicle, pH 7.0
    Reporting group description
    		 Two sprays in each nostril twice a day for up to 12 months

    Serious adverse events
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 421 (1.90%)
    7 / 417 (1.68%)
    14 / 422 (3.32%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cystostomy closure
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Internal fixation of fracture
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fusion surgery
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menstruation irregular
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 421 (0.24%)
    1 / 417 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         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
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intravertebral disc protrusion
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw disorder
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 421 (0.00%)
    0 / 417 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 421 (0.00%)
    1 / 417 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    1 / 421 (0.24%)
    0 / 417 (0.00%)
    0 / 422 (0.00%)
         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: 5%
    Non-serious adverse events
    		 PATANASE Patanase Vehicle, pH 3.7 Patanase Vehicle, pH 7.0
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    220 / 421 (52.26%)
    213 / 417 (51.08%)
    214 / 422 (50.71%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    31 / 421 (7.36%)
    28 / 417 (6.71%)
    37 / 422 (8.77%)
         occurrences all number
    41
    34
    57
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 421 (5.70%)
    27 / 417 (6.47%)
    25 / 422 (5.92%)
         occurrences all number
    32
    38
    38
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    92 / 421 (21.85%)
    76 / 417 (18.23%)
    85 / 422 (20.14%)
         occurrences all number
    159
    117
    136
    Nasal ulcer
         subjects affected / exposed
    31 / 421 (7.36%)
    27 / 417 (6.47%)
    35 / 422 (8.29%)
         occurrences all number
    38
    39
    46
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    50 / 421 (11.88%)
    51 / 417 (12.23%)
    48 / 422 (11.37%)
         occurrences all number
    70
    81
    66
    Rhinitis
         subjects affected / exposed
    51 / 421 (12.11%)
    59 / 417 (14.15%)
    61 / 422 (14.45%)
         occurrences all number
    81
    94
    100
    Sinusitis
         subjects affected / exposed
    55 / 421 (13.06%)
    48 / 417 (11.51%)
    49 / 422 (11.61%)
         occurrences all number
    71
    59
    62
    Upper respiratory tract infection
         subjects affected / exposed
    36 / 421 (8.55%)
    52 / 417 (12.47%)
    45 / 422 (10.66%)
         occurrences all number
    43
    64
    49

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jun 2009
    This study was amended following comments received from the Health Authority. At the time of the amendment’s implementation, 234 patients were enrolled in the study. Because the amendment substantially revised the study plan, the analysis variables, and the entry criteria, all of the active patients at the time the amendment was implemented were discontinued and an entirely new cohort of patients was subsequently enrolled.

    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
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    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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