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    Clinical Trial Results:
    Randomised, double-blind, dose-finding Phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplatin- or anthracycline/ cyclophosphamide (AC)-based chemotherapy

    Summary
    EudraCT number
    		 2013-001635-51
    Trial protocol
    		 GB   DE   DK  
    Global end of trial date
    16 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DN10016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01857232
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Acacia Pharma Ltd
    Sponsor organisation address
    Harston Mill, Harston, Cambridge, United Kingdom, CB22 7GG
    Public contact
    Dr Gabriel Fox, Acacia Pharma Ltd, 00234 1223875130, gabrielfox@acaciapharma.com
    Scientific contact
    Dr Gabriel Fox, Acacia Pharma Ltd, 00234 1223875130, gabrielfox@acaciapharma.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
    16 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine how effective APD403 is at different doses at preventing sickness in patients given chemotherapy and to see if there is any relationship between the effectiveness and the dose.
    Protection of trial subjects
    Before commencing the conduct of any of the pre-study procedures,the investigator or medical delegate explained the study fully to each patient. If the patient was willing to participate in the study they were requested to give written informed consent and sufficient time was given to consider their participation and the opportunity to ask further details.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    15 Jul 2013
    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 Kingdom: 147
    Country: Number of subjects enrolled
    Denmark: 73
    Country: Number of subjects enrolled
    Germany: 108
    Worldwide total number of subjects
    328
    EEA total number of subjects
    328
    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)
    57
    From 65 to 84 years
    271
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Actual: 342 (320 completed). Analysed (intent-to-treat [ITT]): 328 (Placebo 66, APD403 10 mg 63, 20 mg 68, 40 mg 65, DEX 66) Analysed (per protocol [PP]): 318 (Placebo 65, APD403 10 mg 59, 20 mg 67, 40 mg 64,DEX 63) Analysed (safety): 328 (Placebo 66, APD403 10 mg 63, 20 mg 68, 40 mg 65, DEX 66).

    Pre-assignment
    Screening details
    		 Patients were screened up to 14 days before the planned date of their operation and admitted to hospital on the day before or morning of their operation

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1 (DEX)
    Arm description
    		 IV Ondasetron 8mg + IV Fosaprepitant 150mg + IV Dexamethasone 12mg + PO Dexamethasone 8mg (Day2-4)
    Arm type
    		 Control

    Investigational medicinal product name
    Intravenous Dexamethasone
    Investigational medicinal product code
    IV DEX
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    12mg solution for IV injections

    Investigational medicinal product name
    Intravenous Fosaprepitant
    Investigational medicinal product code
    IV FOS
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg Solution for IV injection (Ivemend®; 1 mg/mL in normal saline)

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    OND
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    OND was being used in line with its marketing authorisation and was not specifically under investigation in this study, so it did not meet the usual criteria defining an IMP, as described, for example, in ‘The rules governing medicinal products in the EU. OND was not supplied separately for the study and was to be acquired by study sites according to their normal practice.

    Investigational medicinal product name
    Oral Dexamethasone
    Investigational medicinal product code
    PO-DEX
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 8mg for oral use

    Arm title
    		 Arm 2 (Placebo)
    Arm description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral Placebo of APD403 (Days 2-4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    OND
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    OND was being used in line with its marketing authorisation and was not specifically under investigation in this study, so it did not meet the usual criteria defining an IMP, as described, for example, in ‘The rules governing medicinal products in the EU. OND was not supplied separately for the study and was to be acquired by study sites according to their normal practice.

    Investigational medicinal product name
    IV APD403 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2omg dose of APD403 given via IV

    Investigational medicinal product name
    Oral Placebo of APD403
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules given via oral administration

    Arm title
    		 Arm 3 (APD403 10mg)
    Arm description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od (Days 2-4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    OND
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    OND was being used in line with its marketing authorisation and was not specifically under investigation in this study, so it did not meet the usual criteria defining an IMP, as described, for example, in ‘The rules governing medicinal products in the EU. OND was not supplied separately for the study and was to be acquired by study sites according to their normal practice.

    Investigational medicinal product name
    IV APD403 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2omg dose of APD403 given via IV

    Investigational medicinal product name
    Oral APD403 20mg od
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    APD403 20mg Capsule given Orally

    Arm title
    		 Arms 4 (APD403 20mg)
    Arm description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od ( Days 2-4)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    OND
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    OND was being used in line with its marketing authorisation and was not specifically under investigation in this study, so it did not meet the usual criteria defining an IMP, as described, for example, in ‘The rules governing medicinal products in the EU. OND was not supplied separately for the study and was to be acquired by study sites according to their normal practice.

    Investigational medicinal product name
    Oral APD403 20mg od
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    APD403 20mg Capsule given Orally

    Investigational medicinal product name
    IV APD403 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2omg dose of APD403 given via IV

    Arm title
    		 Arm 5 (APD403 40mg)
    Arm description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 40mg od
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    OND
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    OND was being used in line with its marketing authorisation and was not specifically under investigation in this study, so it did not meet the usual criteria defining an IMP, as described, for example, in ‘The rules governing medicinal products in the EU. OND was not supplied separately for the study and was to be acquired by study sites according to their normal practice.

    Investigational medicinal product name
    IV APD403 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2omg dose of APD403 given via IV

    Investigational medicinal product name
    Oral APD403 40mg od
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40mg capsules given orally

    Number of subjects in period 1
    		Arm 1 (DEX) Arm 2 (Placebo) Arm 3 (APD403 10mg) Arms 4 (APD403 20mg) Arm 5 (APD403 40mg)
    Started
    66
    66
    63
    68
    65
    Completed
    61
    65
    63
    68
    63
    Not completed
    5
    1
    0
    0
    2
         Consent withdrawn by subject
    1
    1
    -
    -
    -
         Adverse event, non-fatal
    4
    -
    -
    -
    -
         Protocol deviation
    -
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1 (DEX)
    Reporting group description
    		 IV Ondasetron 8mg + IV Fosaprepitant 150mg + IV Dexamethasone 12mg + PO Dexamethasone 8mg (Day2-4)

    Reporting group title
    Arm 2 (Placebo)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral Placebo of APD403 (Days 2-4)

    Reporting group title
    Arm 3 (APD403 10mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od (Days 2-4)

    Reporting group title
    Arms 4 (APD403 20mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od ( Days 2-4)

    Reporting group title
    Arm 5 (APD403 40mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 40mg od

    Reporting group values
    		 Arm 1 (DEX) Arm 2 (Placebo) Arm 3 (APD403 10mg) Arms 4 (APD403 20mg) Arm 5 (APD403 40mg) Total
    Number of subjects
    		 66 66 63 68 65 328
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 50 45 48 55 52 250
        From 65-84 years
    		 16 21 15 13 13 78
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.1 ( 10.38 ) 57.3 ( 11.01 ) 56.9 ( 11.24 ) 56.6 ( 11.24 ) 56.5 ( 10.59 ) -
    Gender categorical
    Units: Subjects
        Female
    		 53 52 49 54 54 262
        Male
    		 13 14 14 14 11 66
    Subject analysis sets

    Subject analysis set title
    Enrolled Patient Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who were randomised into the study

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients who received at least one dose of APD403 or DEX or the matching placebo. Patients were summarised according to the treatment actually taken

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who met the criteria for the ITT population and, in addition to the following:- - Had received a correct dose of day 1 study medication; and - had received the day 2 oral dose of study medication; and - were otherwise adherent to the protocol with no major protocol violations, as decided and documented prior to database lock

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This is solely Identical to the ITT population. All enrolled patients were listed indicating their membership of each analysis population. The listing included the patient’s randomisation number and reasons for exclusion from the analysis populations as appropriate.

    Subject analysis sets values
    		 Enrolled Patient Population ITT PP Safety Population
    Number of subjects
    328
    328
    318
    328
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    250
    314
    294
    314
        From 65-84 years
    92
    14
    24
    14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    262
    262
    262
        Male
    66
    66
    66

    End points

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    End points reporting groups
    Reporting group title
    Arm 1 (DEX)
    Reporting group description
    		 IV Ondasetron 8mg + IV Fosaprepitant 150mg + IV Dexamethasone 12mg + PO Dexamethasone 8mg (Day2-4)

    Reporting group title
    Arm 2 (Placebo)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral Placebo of APD403 (Days 2-4)

    Reporting group title
    Arm 3 (APD403 10mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od (Days 2-4)

    Reporting group title
    Arms 4 (APD403 20mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od ( Days 2-4)

    Reporting group title
    Arm 5 (APD403 40mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 40mg od

    Subject analysis set title
    Enrolled Patient Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who were randomised into the study

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients who received at least one dose of APD403 or DEX or the matching placebo. Patients were summarised according to the treatment actually taken

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who met the criteria for the ITT population and, in addition to the following:- - Had received a correct dose of day 1 study medication; and - had received the day 2 oral dose of study medication; and - were otherwise adherent to the protocol with no major protocol violations, as decided and documented prior to database lock

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This is solely Identical to the ITT population. All enrolled patients were listed indicating their membership of each analysis population. The listing included the patient’s randomisation number and reasons for exclusion from the analysis populations as appropriate.

    Primary: Delayed phase complete response (CR)

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    End point title
    		 Delayed phase complete response (CR) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.
    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: To characterise the dose-response of oral APD403 for the prevention of delayed phase nausea and vomiting in male and female patients receiving cisplatin-based chemotherapy and female patients receiving anthracycline and cyclophosphamide (AC)-based chemotherapy, regimens both considered highly emetogenic.
    End point values
    		 Arm 1 (DEX) Arm 2 (Placebo) Arm 3 (APD403 10mg) Arms 4 (APD403 20mg) Arm 5 (APD403 40mg) Enrolled Patient Population ITT PP Safety Population
    Number of subjects analysed
    66
    66
    63
    68
    65
    342
    328
    318
    328
    Units: absence of emetic episodes and no rescue
    37
    13
    27
    21
    20
    118
    118
    118
    118
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any AE that was serious, occurring during the course of the study, irrespective of the treatment received by the patient, had to be reported to the pharmacovigilance contractor within 24 hours of its occurrence
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Arm 1 (DEX)
    Reporting group description
    		 IV Ondasetron 8mg + IV Fosaprepitant 150mg + IV Dexamethasone 12mg + PO Dexamethasone 8mg (Day2-4)

    Reporting group title
    Arm 2 (Placebo)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral Placebo of APD403 (Days 2-4)

    Reporting group title
    Arm 3 (APD403 10mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od (Days 2-4)

    Reporting group title
    Arms 4 (APD403 20mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 20mg od ( Days 2-4)

    Reporting group title
    Arm 5 (APD403 40mg)
    Reporting group description
    		 IV Ondensotron 8mg + IV APD403 20mg + Oral APD403 40mg od

    Serious adverse events
    		 Arm 1 (DEX) Arm 2 (Placebo) Arm 3 (APD403 10mg) Arms 4 (APD403 20mg) Arm 5 (APD403 40mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 66 (7.58%)
    3 / 66 (4.55%)
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    2 / 65 (3.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Cardiac disorders
    CARDIAC ARREST
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    Gastrointestinal disorders
    Duodenal Obstruction
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    Vomiting
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 66 (1.52%)
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemoptysis
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 66 (1.52%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    NEUTROPENIC SEPSIS
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 66 (1.52%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1 (DEX) Arm 2 (Placebo) Arm 3 (APD403 10mg) Arms 4 (APD403 20mg) Arm 5 (APD403 40mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 66 (34.85%)
    17 / 66 (25.76%)
    17 / 63 (26.98%)
    8 / 68 (11.76%)
    14 / 65 (21.54%)
    Investigations
    Blood prolactin increased
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 66 (1.52%)
    3 / 63 (4.76%)
    1 / 68 (1.47%)
    3 / 65 (4.62%)
         occurrences all number
    3
    2
    3
    1
    3
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 66 (1.52%)
    1 / 63 (1.59%)
    2 / 68 (2.94%)
    0 / 65 (0.00%)
         occurrences all number
    1
    1
    1
    2
    0
    Blood and lymphatic system disorders
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 66 (19.70%)
    13 / 66 (19.70%)
    13 / 63 (20.63%)
    5 / 68 (7.35%)
    11 / 65 (16.92%)
         occurrences all number
    13
    13
    13
    5
    11
    Malaise
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 66 (0.00%)
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Sep 2013
    Amendments made during this time are as follows:- •Restriction of 16 mg OND to patients with no evidence of moderate or severe hepatic impairment. • Changes to inclusion criterion 5 and exclusion criterion 4. • Changes to the wording for efficacy assessments relating to vomiting, retching and nausea. • Changes to the wording for ECG assessments. • Addition of a section to describe Rules for Early Termination of the Study if patients suffered specific AEs.
    10 Sep 2013
    Country specific amendments were made for UK and Denmark. They include the following:- • Changes to exclusion criterion 4. • Changes to the wording for efficacy assessments relating to vomiting, retching and nausea. • Changes to the wording for ECG assessments. • Additional text to the section describing the sample size determination.
    15 Oct 2013
    A country specific amendment was made to Germany which include the following:- •Changes to exclusion criterion 11 – addition of azithromycin and deletion of cisapride. • Additional text to the section describing the sample size determination. • Addition of Appendix 8 – insertion of a list of QT-prolonging drugs to be avoided as concomitant.

    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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