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    Clinical Trial Results:
    A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole, and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

    Summary
    EudraCT number
    		 2020-003319-91
    Trial protocol
    		 HU   CZ   BG  
    Global end of trial date
    01 Sep 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Dec 2023
    First version publication date
    15 Sep 2023
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    changes added

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CX842A2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05055128
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cinclus Pharma AG
    Sponsor organisation address
    Gartenstrasse 101, Basel, Switzerland,
    Public contact
    Kajsa Larsson, Cinclus Pharma AG, +46 706750128, kajsa.larsson@cincluspharma.com
    Scientific contact
    Kajsa Larsson, Cinclus Pharma AG, +46 706750128, kajsa.larsson@cincluspharma.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the safety and tolerability of X842 after single and multiple oral dose administration in healthy subjects
    Protection of trial subjects
    This study was performed in accordance with the protocol and ethical principles that have their origin in the Declaration of Helsinki (version 2013, 7th revision) and are consistent with ICH/GCP E6 (R2), EU Clinical Trials Directive, and applicable local regulatory requirements. Before performing any study related procedures, the ICF was signed and personally dated by the patient (or their legally acceptable representative and/or witness, as applicable) and by the Investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Ukraine: 10
    Country: Number of subjects enrolled
    Bulgaria: 87
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    Georgia: 77
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Poland: 51
    Country: Number of subjects enrolled
    Serbia: 3
    Worldwide total number of subjects
    248
    EEA total number of subjects
    156
    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)
    197
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 36 centers which included 248 patients across 08 countries. The trial began on 11 Aug 2021 (first patient enrolled) and was completed on 01 Sep 2022 (Last patient completed).

    Pre-assignment
    Screening details
    		 The pre-treatment assessments were performed during the screening period (Day -7 to Day 0) prior to the first dose preferably. All the study assessments were performed as per the schedule of assessments.

    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
    Blinding implementation details
    Due to tool limitations the double-blind period and open-label arms were presented here under the overall study period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 X842 25 mg BID (Double-blind Period)
    Arm description
    		 Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 25 mg+ X842 dummy) in the evening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    X842
    Investigational medicinal product code
    X842
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    Lansoprazole dummy
    Investigational medicinal product code
    Lansoprazole dummy
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    X842 dummy
    Investigational medicinal product code
    X842 dummy
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Arm title
    		 X842 50 mg BID (Double-blind Period)
    Arm description
    		 Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 dummy) in the evening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    X842
    Investigational medicinal product code
    X842
    Other name
    X842
    Pharmaceutical forms
    Tablet
    Routes of administration
    Other use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    Lansoprazole dummy
    Investigational medicinal product code
    Lansoprazole dummy
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    X842 dummy
    Investigational medicinal product code
    X842 dummy
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Arm title
    		 X842 75 mg BID (Double-blind Period)
    Arm description
    		 Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 25 mg) in the evening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lansoprazole dummy
    Investigational medicinal product code
    Lansoprazole dummy
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    X842
    Investigational medicinal product code
    X842
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Arm title
    		 X842 100 mg BID (Double-blind Period)
    Arm description
    		 Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg×2) in the evening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lansoprazole dummy
    Investigational medicinal product code
    Lansoprazole dummy
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    X842
    Investigational medicinal product code
    X842
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Arm title
    		 Lansoprazole (Open-label Period)
    Arm description
    		 Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lansoprazole
    Investigational medicinal product code
    Lansoprazole
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Investigational medicinal product name
    X842 dummy
    Investigational medicinal product code
    X842 dummy
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Number of subjects in period 1
    		X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Started
    51
    48
    52
    47
    50
    Completed
    45
    45
    50
    41
    47
    Not completed
    6
    3
    2
    6
    3
         Consent withdrawn by subject
    5
    2
    2
    4
    2
         Adverse event, non-fatal
    -
    -
    -
    1
    1
         Other
    1
    -
    -
    -
    -
         Randomized by mistake
    -
    1
    -
    -
    -
         Protocol deviation
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    X842 25 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 25 mg+ X842 dummy) in the evening.

    Reporting group title
    X842 50 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 dummy) in the evening.

    Reporting group title
    X842 75 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 25 mg) in the evening.

    Reporting group title
    X842 100 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg×2) in the evening.

    Reporting group title
    Lansoprazole (Open-label Period)
    Reporting group description
    		 Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening

    Reporting group values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period) Total
    Number of subjects
    		 51 48 52 47 50 248
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 42 41 45 31 38 197
        From 65-84 years
    		 9 7 7 16 12 51
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.7 ± 15.99 45.3 ± 14.11 48.7 ± 14.05 54.8 ± 13.26 49.1 ± 15.41 -
    Gender categorical
    Units: Subjects
        Female
    		 18 19 22 17 20 96
        Male
    		 33 29 30 30 30 152

    End points

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    End points reporting groups
    Reporting group title
    X842 25 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 25 mg+ X842 dummy) in the evening.

    Reporting group title
    X842 50 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 dummy) in the evening.

    Reporting group title
    X842 75 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg+ X842 25 mg) in the evening.

    Reporting group title
    X842 100 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning and 2 tablets (X842 50 mg×2) in the evening.

    Reporting group title
    Lansoprazole (Open-label Period)
    Reporting group description
    		 Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening

    Primary: Number of Patients With Esophageal Mucosa Healing

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    End point title
    		 Number of Patients With Esophageal Mucosa Healing [1]
    End point description
    The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection LG, through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. The full analysis set (FAS) consisted of all patients who had been randomized and received at least 1 dose of study drug. FAS erosive is a subset of FAS consisted of patients who had been classified as erosive (Grade A, B, C or D) as screening according to the central reading or imputed by local reading if missing.
    End point type
    Primary
    End point timeframe
    Week 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis performed for this endpoint.
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    38
    37
    41
    33
    33
    Units: Participants
    28
    28
    32
    18
    20
    No statistical analyses for this end point

    Secondary: Number of Patients With Adverse Events (AEs)

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    End point title
    		 Number of Patients With Adverse Events (AEs)
    End point description
    Safety and tolerability of 4 doses of LG and Lansoprazole were evaluated, where LAN served as the active comparator. TEAE-Treatment-emergent adverse event, ADR-Adverse drug reaction, SAE-Serious adverse event, and AESI-Adverse events of special interest. The safety analysis set consisted of all patients who had been randomized and received at least 1 dose of study drug. Patients were analyzed according to the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From Screening (Day -7 to Day 0) until Week 8
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    51
    48
    52
    47
    50
    Units: Participants
        Any AE
    15
    10
    12
    11
    10
        Any TEAE
    14
    10
    12
    11
    10
        Any severe TEAE
    1
    0
    0
    0
    0
        Any treatment related TEAE (ADR)
    4
    2
    0
    2
    2
        Any TEAE leading to study discontinuation
    1
    0
    0
    1
    0
        Any SAE
    1
    0
    1
    0
    0
        Any Serious TEAE
    1
    0
    1
    0
    0
        Any treatment emergent AESI
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Heartburn-Free 24-hour Days

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    End point title
    		 Percentage of Heartburn-Free 24-hour Days
    End point description
    Heartburn-free in a 24-hour day was defined as a day where the patient reported having no burning feeling or pain behind the breast or in the center of the upper stomach (score of 0) for both morning and evening. The percentage of heartburn-free 24-hour days based on eDiary (Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. The reflux-related symptom pattern was evaluated during the initial 4 weeks of treatment with four dose levels of LG and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks (Weeks 5-8) of open-label treatment with Lansoprazole. Modified RESQ-eDiary was a validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains [i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max: 0-15) and Regurgitations/Reflux (min-max: 0-8)]. The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Weeks 1 and 8
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    51
    48
    52
    47
    50
    Units: Percentage of days
    arithmetic mean (standard deviation)
        Week 1 (n=48, 46, 51, 46, 48)
    27.0 ± 5.80
    25.1 ± 5.91
    29.2 ± 5.56
    26.1 ± 5.86
    19.1 ± 5.68
        Week 8 (n=31, 34, 34, 29, 32)
    82.4 ± 6.59
    73.8 ± 6.51
    78.6 ± 6.19
    72.2 ± 6.78
    59.2 ± 6.48
    No statistical analyses for this end point

    Secondary: Percentage of at Most-mild Heartburn 24-hour Days

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    End point title
    		 Percentage of at Most-mild Heartburn 24-hour Days
    End point description
    Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 1 and 8
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    51
    48
    52
    47
    50
    Units: Percentage of days
    arithmetic mean (standard deviation)
        Week 1 (n=48, 46, 51, 46, 48)
    75.3 ± 3.78
    67.9 ± 3.85
    79.4 ± 3.62
    69.7 ± 3.81
    63.1 ± 3.70
        Week 8 (n=31, 34, 34, 29, 32)
    98.5 ± 4.34
    96.5 ± 4.27
    95.8 ± 4.08
    97.1 ± 4.46
    92.2 ± 4.26
    No statistical analyses for this end point

    Secondary: Investigator Assessment of Symptoms by Frequency and Severity

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    End point title
    		 Investigator Assessment of Symptoms by Frequency and Severity
    End point description
    Investigator assessed the severity and frequency (FRQ) of patients’ heartburn (HB), regurgitation/reflux (R/R) and dysphagia (DYS) in the 7 days prior to visit. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and the FRQ (for FRQ, 7-graded Likert scale was used, ranging from none of the time to all of the time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). For FRQ- All of the time and None of the time, and for symptoms- none and severe data has been presented. The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. WK- week
    End point type
    Secondary
    End point timeframe
    Weeks 1 and 8
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    51
    48
    52
    47
    50
    Units: Participants
        WK1 (DYS) FRQ AT (n=50, 46, 50, 45, 47)
    0
    2
    0
    1
    0
        WK1 (DYS) FRQ NT (n=50, 46, 50, 45, 47)
    14
    10
    13
    13
    11
        WK8 (DYS) FRQ AT (n=48, 46, 50, 42, 48)
    0
    0
    0
    1
    0
        WK8 (DYS) FRQ NT (n=48, 46, 50, 42, 48)
    42
    37
    43
    34
    40
        WK1 (HB) FRQ AT (n=50, 46, 50, 45, 47)
    4
    0
    3
    3
    3
        WK1 (HB) FRQ NT (n=50, 46, 50, 45, 47)
    1
    0
    4
    4
    1
        WK8 (HB) FRQ AT (n=48, 46, 50, 42, 48)
    0
    0
    0
    0
    0
        WK8 (HB) FRQ NT (n=48, 46, 50, 42, 48)
    38
    37
    43
    33
    36
        WK1 (R/R) FRQ AT (n=50, 46, 50, 45, 47)
    1
    0
    2
    1
    0
        WK1 (R/R) FRQ NT (n=50, 46, 50, 45, 47)
    1
    2
    4
    4
    3
        WK8 (R/R) FRQ AT (n=48, 46, 50, 42, 48)
    0
    0
    0
    1
    0
        WK8 (R/R) FRQ NT (n=48, 46, 50, 42, 48)
    41
    36
    41
    32
    39
        WK1 (DYS) Symptom-None (n=50, 46, 50, 45, 47)
    14
    12
    13
    15
    12
        WK1 (DYS) Symptom-Severe (n=50, 46, 50, 45, 47)
    1
    2
    2
    2
    1
        WK8 (DYS) Symptom-None (n=48, 46, 50, 42, 48)
    42
    37
    43
    35
    41
        WK8 (DYS) Symptom-Severe (n=48, 46, 50, 42, 48)
    0
    0
    0
    0
    0
        WK1 (HB) Symptom-None (n=50, 46, 50, 45, 47)
    1
    0
    4
    5
    1
        WK1 (HB) Symptom-Severe (n=50, 46, 50, 45, 47)
    5
    1
    4
    2
    3
        WK8 (HB) Symptom-None (n=48, 46, 50, 42, 48)
    38
    37
    44
    33
    38
        WK8 (HB) Symptom-Severe (n=48, 46, 50, 42, 48)
    1
    0
    1
    0
    0
        WK1 (R/R) Symptom-None (n=50, 46, 50, 45, 47)
    1
    3
    6
    5
    3
        WK1 (R/R) Symptom-Severe (n=50, 46, 50, 45, 47)
    3
    3
    5
    4
    2
        WK8 (R/R) Symptom-None (n=48, 46, 50, 42, 48)
    41
    36
    41
    33
    41
        WK8 (R/R) Symptom-Severe (n=48, 46, 50, 42, 48)
    0
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score

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    End point title
    		 Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
    End point description
    The reflux-related symptom pattern was evaluated during the initial 4 weeks treatment with four dose levels of X842 and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks open-label treatment with Lansoprazole 30 mg QD. The heartburn version of the Quality of Life in Reflux and Dyspepsia (QOLRAD) is a disease specific instrument and contained 25 questions addressing concerns associated with gastrointestinal symptoms. The questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as the score increased, the patient's condition was considered better. The questions were categorized into 5 domains: emotional distress, sleep disturbance (SD), vitality, food/drink problems, and physical/social (P/S) functioning. The score ranges from 1 to 175, higher scores mean a better outcome. The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. WK- week
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, and 8
    End point values
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg BID (Double-blind Period) X842 100 mg BID (Double-blind Period) Lansoprazole (Open-label Period)
    Number of subjects analysed
    51
    48
    52
    47
    50
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        WK1 Emotional Distress Score (n= 40,40,41,34,41)
    1.69 ± 0.247
    1.55 ± 0.251
    1.14 ± 0.233
    1.54 ± 0.255
    1.34 ± 0.241
        WK8 Emotional Distress Score (n= 27,24,27,22,23)
    2.76 ± 0.265
    2.51 ± 0.275
    1.84 ± 0.253
    2.00 ± 0.278
    2.19 ± 0.269
        WK1 Food/Drink Problems Score (n= 40,40,41,34,41)
    1.84 ± 0.229
    1.62 ± 0.232
    1.32 ± 0.217
    1.65 ± 0.238
    1.40 ± 0.223
        WK8 Food/Drink Problems Score (n= 27,24,27,22,23)
    3.08 ± 0.249
    2.97 ± 0.259
    2.34 ± 0.240
    2.28 ± 0.264
    2.56 ± 0.256
        WK1 P/S Functioning Score (n= 40,40,41,34,41)
    1.26 ± 0.247
    1.32 ± 0.252
    1.02 ± 0.233
    1.19 ± 0.255
    0.97 ± 0.241
        WK8 P/S Functioning Score (n= 27,24,27,22,23)
    2.06 ± 0.262
    2.26 ± 0.271
    1.57 ± 0.249
    1.60 ± 0.274
    1.71 ± 0.265
        WK1 SD Score (n= 40,40,41,34,41)
    1.60 ± 0.250
    1.45 ± 0.255
    1.08 ± 0.236
    1.49 ± 0.258
    1.54 ± 0.244
        WK8 SD Score (n= 27,24,27,22,23)
    2.78 ± 0.266
    2.48 ± 0.276
    1.89 ± 0.254
    1.91 ± 0.279
    2.37 ± 0.270
        WK1 Vitality Score (n= 40,40,41,34,41)
    1.55 ± 0.237
    1.51 ± 0.240
    1.42 ± 0.224
    1.50 ± 0.246
    1.21 ± 0.231
        WK8 Vitality Score (n= 27,24,27,22,23)
    2.84 ± 0.257
    2.79 ± 0.268
    2.25 ± 0.247
    2.21 ± 0.272
    2.19 ± 0.264
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Day -7 to Day 0) until Week 8
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    X842 25 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Reporting group title
    X842 50 mg BID (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Reporting group title
    X842 75 mg (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Reporting group title
    X842 100 mg (Double-blind Period)
    Reporting group description
    		 Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Reporting group title
    Lansoprazole (Open-label Period)
    Reporting group description
    		 Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

    Serious adverse events
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg (Double-blind Period) X842 100 mg (Double-blind Period) Lansoprazole (Open-label Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Laryngospasm
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (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: 0%
    Non-serious adverse events
    		 X842 25 mg BID (Double-blind Period) X842 50 mg BID (Double-blind Period) X842 75 mg (Double-blind Period) X842 100 mg (Double-blind Period) Lansoprazole (Open-label Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 51 (27.45%)
    10 / 48 (20.83%)
    12 / 52 (23.08%)
    11 / 47 (23.40%)
    10 / 50 (20.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Mucosal dryness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hepatobiliary disorders
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Laryngospasm
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 48 (6.25%)
    1 / 52 (1.92%)
    1 / 47 (2.13%)
    1 / 50 (2.00%)
         occurrences all number
    1
    3
    1
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 48 (2.08%)
    2 / 52 (3.85%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Eructation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    2 / 47 (4.26%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Gastrointestinal hypermotility
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    0
    0
    4
    Oesophageal pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 48 (4.17%)
    0 / 52 (0.00%)
    2 / 47 (4.26%)
    0 / 50 (0.00%)
         occurrences all number
    0
    3
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Purpura
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 48 (4.17%)
    1 / 52 (1.92%)
    4 / 47 (8.51%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    1
    4
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 48 (4.17%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 47 (2.13%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jul 2019
    Amendment 1: Inclusion criteria- lansoprazole was excluded from the primary treatment. Change in 5 days to 7 days was done based on extension of screening period. Reflux Related Symptoms Assessed Based on PRO- Modified RESQeDiary added for clarity and “every 12-hours” was added to be more specific in reporting time. Reflux Related Symptoms Assessed by Investigator-Text updated to define frequency of symptoms on 7-graded Likert scale.
    25 Feb 2022
    Amendment 2: Study Population- Text updated to clarify criteria for patients identified during their routine endoscopy and for patients invited for screening endoscopy based on their past medical history.

    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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