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    Clinical Trial Results:
    Evaluation of the effect of Gerdoff administered in combination to a treatment with protonic pump inhibitors vs the only treatment with protonic pump inhibitors, administered for 6 weeks, on higher symptoms associated to gerd, in patients with first diagnosis of gastroesophageal reflux disease. An open, multicentre, prospective, randomized, double parallel treatment arms study.

    Summary
    EudraCT number
    		 2016-004503-31
    Trial protocol
    		 IT  
    Global end of trial date
    11 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2019
    First version publication date
    27 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PSC-DSGERDAP16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03793556
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sofar Spa
    Sponsor organisation address
    Via Firenze, 40, Trezzano Rosa, Italy, 20060
    Public contact
    Direzione Scientifica, SOFAR S.p.A., 0039 02 9093621, francesca.baldan@sofarfarm.it
    Scientific contact
    Direzione Scientifica, SOFAR S.p.A., 0039 02 9093621, walter.fiore@sofarfarm.it
    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
    19 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the capacity of GERDOFF to improve upper symptoms related to diagnosis of GERD in association with PPI (omeprazole) vs. the only treatment with PPI (omeprazole) during 6 weeks of treatment and during the following retention period of 12 weeks.
    Protection of trial subjects
    To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients who continued in the follow-up period received omeprazole as rescue medication in a quantity adequate to cover the entire follow-up period. This therapy was chosen by the study coordinator as it was commonly used in clinical practice to treat all specific and non-specific symptoms of GERD. The investigator explained to patients that rescue omeprazole could be taken only if necessary and according to the indications given by the Investigator, at constant dosage, and that use was to be recorded in the daily diary by indicating the reason for administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2017
    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
    Italy: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    62
    From 65 to 84 years
    9
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A first specialist visit was performed by an ENT as per clinical practice based on patient’s symptoms. Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients.

    Pre-assignment
    Screening details
    		 The main inclusion criteria were: male or female subjects aged ≥ 18 years; first diagnosis of GERD with upper symptoms; presence of extra-oesophageal symptoms associtated with GERD; RSI score ≥ 20; patients not pre-treated with proton pump inhibitors in the previous 4 weeks; patients able to give the informed consent.

    Pre-assignment period milestones
    Number of subjects started
    		 72
    Number of subjects completed
    		 71

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omeprazole
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Two 20 mg capsules once daily in the morning before breakfast. Treatment duration: 6 weeks ± 2 days.

    Arm title
    		 Gerdoff® + Omeprazole
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Two 20 mg capsules once daily in the morning before breakfast. Treatment duration: 6 weeks ± 2 days.

    Investigational medicinal product name
    Gerdoff®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet three times daily: 1 tablet after breakfast, 1 tablet after lunch and 1 tablet in the evening before retiring to bed. Treatment duration: 6 weeks ± 2 days.

    Number of subjects in period 1 [1]
    		Omeprazole Gerdoff® + Omeprazole
    Started
    36
    35
    Completed
    36
    35
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient was enrolled, but he/she did not end the pre-assignment phase
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omeprazole
    Arm description
    		 Patients randomized to receive omeprazole -two 20 mg capsules once daily- for 6 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Two 20 mg capsules once daily in the morning before breakfast. Treatment duration: 6 weeks ± 2 days.

    Arm title
    		 Gerdoff® + Omeprazole
    Arm description
    		 Patients randomized to receive Gerdoff® -one tablet three times daily- plus omeprazole - two 20 mg capsules once daily-
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gerdoff®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet three times daily: 1 tablet after breakfast, 1 tablet after lunch and 1 tablet in the evening before retiring to bed. Treatment duration: 6 weeks ± 2 days.

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Two 20 mg capsules once daily in the morning before breakfast. Treatment duration: 6 weeks ± 2 days.

    Number of subjects in period 2
    		Omeprazole Gerdoff® + Omeprazole
    Started
    36
    35
    Completed
    34
    22
    Not completed
    2
    13
         Consent withdrawn by subject
    1
    12
         Lost to follow-up
    1
    1
    Period 3
    Period 3 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gerdoff®
    Arm description
    		 Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gerdoff®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet three times daily: 1 tablet after breakfast, 1 tablet after lunch and 1 tablet in the evening before retiring to bed. Treatment duration: 6 weeks ± 2 days.

    Arm title
    		 No treated
    Arm description
    		 Responder patients of Group Gerdoff® + omeprazole were randomly assigned to the control group. All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [2]
    		Gerdoff® No treated
    Started
    10
    8
    Completed
    8
    8
    Not completed
    2
    0
         Lost to follow-up
    2
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In the follow-up period only patients who responded to treatment were included.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omeprazole
    Reporting group description
    		 -

    Reporting group title
    Gerdoff® + Omeprazole
    Reporting group description
    		 -

    Reporting group values
    		 Omeprazole Gerdoff® + Omeprazole Total
    Number of subjects
    		 36 35 71
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 31 30 61
        From 65-84 years
    		 5 4 9
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 45.5 (20 to 76) 46.0 (20 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 32 22 54
        Male
    		 4 13 17
    Patients with simultaneous symptoms
    Units: Subjects
        1 symptom
    		 3 2 5
        2 symptoms
    		 1 5 6
        3 symptoms
    		 6 9 15
        4 symptoms
    		 17 11 28
        5 symptoms
    		 5 5 10
        6 symptoms
    		 3 2 5
        7 symptoms
    		 1 1 2
        Not recorded
    		 0 0 0
    Hoarseness or vocal problem
    Units: Subjects
        yes
    		 18 21 39
        no
    		 18 14 32
    Throat clearance
    Units: Subjects
        yes
    		 23 18 41
        no
    		 13 17 30
    Excess of mucus in the throat or retrosternal fall of secretions
    Units: Subjects
        yes
    		 15 14 29
        no
    		 21 21 42
    Difficulty in swallowing food, fluids or pills
    Units: Subjects
        yes
    		 7 7 14
        no
    		 29 28 57
    Cough after the meal or after lying
    Units: Subjects
        yes
    		 15 13 28
        no
    		 21 22 43
    Difficulty in breathing or episodes of choking
    Units: Subjects
        yes
    		 5 4 9
        no
    		 31 31 62
    Problematic or troublesome cough
    Units: Subjects
        yes
    		 24 16 40
        no
    		 12 19 31
    Sensation of something blocked or mass in the throat
    Units: Subjects
        yes
    		 12 17 29
        no
    		 24 18 42
    Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright
    Units: Subjects
        yes
    		 22 17 39
        no
    		 14 18 32
    Weight
    Units: kg
        median (full range (min-max))
    		 62.0 (43.0 to 95.0) 63.0 (45.0 to 98.6) -
    Body Mass Index
    Units: kg/m2
        median (full range (min-max))
    		 22.7 (16.8 to 38.6) 22.6 (17.6 to 35.2) -
    Number of symptoms
    Units: number
        median (inter-quartile range (Q1-Q3))
    		 4 (1 to 7) 4 (1 to 7) -

    End points

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    End points reporting groups
    Reporting group title
    Omeprazole
    Reporting group description
    		 -

    Reporting group title
    Gerdoff® + Omeprazole
    Reporting group description
    		 -
    Reporting group title
    Omeprazole
    Reporting group description
    		 Patients randomized to receive omeprazole -two 20 mg capsules once daily- for 6 weeks

    Reporting group title
    Gerdoff® + Omeprazole
    Reporting group description
    		 Patients randomized to receive Gerdoff® -one tablet three times daily- plus omeprazole - two 20 mg capsules once daily-
    Reporting group title
    Gerdoff®
    Reporting group description
    		 Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.

    Reporting group title
    No treated
    Reporting group description
    		 Responder patients of Group Gerdoff® + omeprazole were randomly assigned to the control group. All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.

    Primary: Change from baseline to visit V4 of the total score of RSI questionnaire

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    End point title
    		 Change from baseline to visit V4 of the total score of RSI questionnaire
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    -13.7 ± 10.58
    -16.2 ± 7.45
    Statistical analysis title
    		 Change of total RSI score from baseline to V4
    Comparison groups
    Omeprazole v Gerdoff® + Omeprazole
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.276
    Method
    		 Unpaired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.03
         upper limit
    		 2.04
    Variability estimate
    Standard deviation
    Dispersion value
    9.27

    Secondary: Change of the total score of RSI questionnaire from baseline to the other time points

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    End point title
    		 Change of the total score of RSI questionnaire from baseline to the other time points
    End point description
    Data from visit 2 and visit 3 are summarized in the table attached
    End point type
    Secondary
    End point timeframe
    From baseline to visit V2, V3 and V4
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    -13.7 ± 10.58
    -16.2 ± 7.45
    Attachments
    		 Change of the total score V2-V3
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    The ANOVA model examined the entire curve profile.
    Comparison groups
    Omeprazole v Gerdoff® + Omeprazole
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0157
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - The ANOVA model showed a statistically significant treatment effect (F value = 6.13, p = 0.0157) and a statistically significant visit effect (F value = 73.00, p<0.0001), whereas the treatment-by-visit interaction was not statistically significant (F value = 1.07, p = 0.3695).

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of hoarseness or vocal problem

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of hoarseness or vocal problem
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.6 ± 1.54
    1.1 ± 1.33
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of throat clearance

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of throat clearance
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.8 ± 1.37
    1.4 ± 1.39
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of excess of mucus in the throat or retrosternal fall of secretions

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of excess of mucus in the throat or retrosternal fall of secretions
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.9 ± 1.61
    1.4 ± 1.31
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of difficulty in swallowing food, fluids or pills

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of difficulty in swallowing food, fluids or pills
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    0.6 ± 0.94
    0.4 ± 0.71
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of cough after the meal or after lying

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of cough after the meal or after lying
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.7 ± 1.47
    0.7 ± 1.01
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of difficulty in breathing or episodes of choking

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of difficulty in breathing or episodes of choking
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    0.6 ± 0.97
    0.5 ± 1.15
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of problematic or troublesome cough

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of problematic or troublesome cough
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.5 ± 1.54
    0.8 ± 1.17
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score ofsensation of something blocked or mass in the throat

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score ofsensation of something blocked or mass in the throat
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.2 ± 1.45
    0.8 ± 1.34
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 4 of the RSI questionnaire score of stomach burning, thoracic pain, poor digestion of gastric acid that moves upright

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    End point title
    		 Change from baseline to visit 4 of the RSI questionnaire score of stomach burning, thoracic pain, poor digestion of gastric acid that moves upright
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: number
        arithmetic mean (standard deviation)
    1.6 ± 1.59
    0.8 ± 1.08
    No statistical analyses for this end point

    Secondary: Number and percentage of responders V4

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    End point title
    		 Number and percentage of responders V4
    End point description
    A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13.
    End point type
    Secondary
    End point timeframe
    At visit 4 after 6 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: Subject
        YES
    20
    23
        NO
    16
    8
    Attachments
    		 Percentage of responders v4
    Statistical analysis title
    		 Number of responders
    Comparison groups
    Omeprazole v Gerdoff® + Omeprazole
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0496
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number and percentage of responders V6

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    End point title
    		 Number and percentage of responders V6
    End point description
    The rate of responders was 100% in Gerdoff® group and 87.5% in control group
    End point type
    Secondary
    End point timeframe
    In the Visit 6 at the end of follow-up
    End point values
    		 Gerdoff® No treated
    Number of subjects analysed
    9
    8
    Units: subject
        Missing
    0
    0
        Yes
    9
    7
        No
    0
    1
    No statistical analyses for this end point

    Secondary: Change of upper symptoms using the Likert scale from baseline to V4 and V6

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    End point title
    		 Change of upper symptoms using the Likert scale from baseline to V4 and V6
    End point description
    Data related to visit 4 are reported here, while data related to visit 6 are presented in the table attached
    End point type
    Secondary
    End point timeframe
    From baseline to visit 4 after 6 weeks of treatment and to visit 6 after 18 weeks of treatment
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: Score
        arithmetic mean (standard deviation)
    11.6 ± 8.083
    7.4 ± 5.667
    Attachments
    		 Likert V6
    Statistical analysis title
    		 Upper symptoms Likert Scale V4
    Comparison groups
    Omeprazole v Gerdoff® + Omeprazole
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0065 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - ANOVA model showed a significant treatment effects (F value = 7.86, p = 0.0065) and a statistically significant visit effect (F value = 42.32, p<0.0001), whereas the treatment-by-visit interaction was not significant (F value = 0.59, p = 0.6240)

    Secondary: Presence of upper symptoms at baseline, end of treatment, and end of follow-up using the RSI questionnaire and the Likert scale

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    End point title
    		 Presence of upper symptoms at baseline, end of treatment, and end of follow-up using the RSI questionnaire and the Likert scale
    End point description
    Data related to visit 4 are reported here, while data related to visit 6 are presented in the table attached
    End point type
    Secondary
    End point timeframe
    The presence of upper simultaneous symptoms was assessed at baseline, at the visit 4 after 6 weeks of treatment and at the visit 6 after 18 weeks of treatment.
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: subject
        Missing
    4
    1
        1 symptom
    2
    7
        2 symptoms
    9
    6
        3 symptoms
    11
    13
        4 symptoms
    7
    4
        5 symptoms
    2
    0
        6 symptoms
    1
    0
    Attachments
    		 Upper symptoms Likert V6
    No statistical analyses for this end point

    Secondary: Use of rescue medication (omeprazole) during the treatment

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    End point title
    		 Use of rescue medication (omeprazole) during the treatment
    End point description
    Percentage of patients who used omeprazole as rescue medication are reported in the table attached.
    End point type
    Secondary
    End point timeframe
    During the treatment from baseline to visit 4
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: subject
        Missing
    0
    0
        Yes
    28
    24
        No
    8
    11
    Attachments
    		 Rescue Medication
    No statistical analyses for this end point

    Secondary: Use of rescue medication (omeprazole) during the follow-up

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    End point title
    		 Use of rescue medication (omeprazole) during the follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    At visit 6
    End point values
    		 Gerdoff® No treated
    Number of subjects analysed
    9
    8
    Units: subject
        missing
    0
    0
        Yes
    7
    5
        No
    2
    3
    No statistical analyses for this end point

    Secondary: Use of rescue medication (other than omeprazole) during treatment and follow-up

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    End point title
    		 Use of rescue medication (other than omeprazole) during treatment and follow-up
    End point description
    Data related to visit 4 are reported here, data related to visit 6 are reported in the table attached.
    End point type
    Secondary
    End point timeframe
    From baseline to visit 4 and up to visit 6 at the end of follow-up
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    31
    Units: subject
        Missing
    0
    0
        Yes
    4
    0
        No
    32
    31
    No statistical analyses for this end point

    Secondary: Patients'satisfaction

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    End point title
    		 Patients'satisfaction
    End point description
    data related to visit 4 are reported here, data related to other time points and percentages are presented in the table attached.
    End point type
    Secondary
    End point timeframe
    During the treatment at visit 2, visit 3 and visit 4 and at the end of follow-up (visit 6).
    End point values
    		 Omeprazole Gerdoff® + Omeprazole
    Number of subjects analysed
    36
    35
    Units: subject
        Missing
    0
    3
        Low
    1
    3
        Discrete
    7
    1
        Good
    11
    11
        Excellent
    17
    15
    Attachments
    		 Satisfaction
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the enrollment to the end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Omeprazole
    Reporting group description
    		 -

    Reporting group title
    Gerdoff® + Omeprazole
    Reporting group description
    		 -

    Serious adverse events
    		 Omeprazole Gerdoff® + Omeprazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial Fibrillation
    Additional description: Mild intensity atrial fibrillation, not related to treatment
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Omeprazole Gerdoff® + Omeprazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 36 (33.33%)
    14 / 35 (40.00%)
    Investigations
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Clonus
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Flu-like symptoms
         subjects affected / exposed
    2 / 36 (5.56%)
    3 / 35 (8.57%)
         occurrences all number
    2
    5
    Chills
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 36 (8.33%)
    4 / 35 (11.43%)
         occurrences all number
    3
    4
    Diarrhoea
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Dysentery
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    neck pain
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Sinusitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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