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    Clinical Trial Results:
    EMPOWER: EMesis in Pregnancy - Ondansetron With mEtoclopRamide.

    Summary
    EudraCT number
    		 2017-001651-31
    Trial protocol
    		 GB  
    Global end of trial date
    02 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2020
    First version publication date
    24 Oct 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    5.0
    Additional study identifiers
    ISRCTN number
    		 ISRCTN16924692
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC Reference : 17/NE/0325 , NUTH Sponsor Reference : 8367, NIHR HTA Funder Reference: 16/15/03
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Freeman Road, Newcastle upon Tyne , United Kingdom, NE7 7DN
    Public contact
    Professor Stephen Courtenay Robson, Newcastle University, +44 0191 282 4132, s.c.robson@newcastle.ac.uk
    Scientific contact
    Professor Stephen Courtenay Robson, Newcastle University, +44 0191 282 4132, s.c.robson@newcastle.ac.uk
    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
    09 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether, in addition to IV rehydration, ondansetron vs placebo ondansetron and metoclopramide vs placebo metoclopramide reduces the rate of treatment failure up to 10 days after initiation.
    Protection of trial subjects
    A DMC was convened to undertake independent review. The purpose of this committee was to monitor safety. At the first meeting, the DMC agreed on its charter of operation and how many times the DMC would meet throughout the course of the study.
    Background therapy
    		 Nausea and vomiting in pregnancy (NVP) affects up to 85% of women in the first half of pregnancy. Symptoms usually start at 6-8 weeks, peak by 9 weeks and for many women subside by 20 weeks gestation. Symptoms are often mild but 30% of sufferers experience more severe symptoms requiring medical intervention. The most severe form, hyperemesis gravidarum (HG), affects 0.3-3% of women and is characterised by intractable vomiting, dehydration, ketonuria and weight loss. HG can result in prolonged hospitalisation, multiple treatments and, where interventions fail, termination of pregnancy. NVP is associated with emotional and psychological distress and has a profound impact on quality of life. Women often feel unsupported, suffer higher rates of depression, anxiety and stress and often feel dissatisfied with care. Women with HG are also more likely to deliver preterm and to have small for gestational age infants although there is no association with congenital anomalies or perinatal death. The aetiology remains unclear and there is no cure for NVP - treatment focuses on relieving symptoms and preventing morbidity. Most women with moderate or severe disease require clinician-initiated interventions in the form of intravenous fluids and antiemetic drugs, primarily antihistamines, dopamine antagonists and 5-HT3 antagonists. Participants were randomised to one of the following regimes: • Metoclopramide (10 mg three times daily [IV + PO]) + placebo [IV + PO] • Ondansetron (4 mg three times daily [IV + PO]) + placebo [IV + PO] • Metoclopramide (10 mg three times daily [IV + PO]) + ondansetron (4 mg three times daily [IV + PO]) • Double placebo three times daily [IV + PO]
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2018
    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 Kingdom: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Clinical staff on duty in the department where pregnant women present for assessment and treatment informed the research team if any women attended suffering from NVP or HG. The clinical team made the first approach to the potential participant. The research team then approached the patient. Participants were recruited between 29/5/18 and 7/8/19.

    Pre-assignment
    Screening details
    		 All women attending secondary care with NVP were assessed for eligibility by the research team and confirmed by a medically qualified doctor trained in GCP. A detailed medical and obstetric history was taken.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was administered centrally by NCTU secure web-based system. Patients were randomised on a 1:1:1:1 basis using a block stratified method (stratified by site) to receive either (1) ondansetron + placebo, (2) metoclopramide + placebo, (3) metoclopramide + ondansetron or (4) double placebo. Assignment to either arm was blinded to both participants and site staff including the PI. IMPs were manufactured and packaged to ensure participants and study staff were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ondansetron plus placebo
    Arm description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron PO 4mg tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Arm title
    		 Metoclopramide plus placebo
    Arm description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metoclopramide plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Arm title
    		 Ondansetron plus Metoclopramide
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus Metoclopramide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Arm title
    		 Double placebo
    Arm description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Double Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Number of subjects in period 1
    		Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Started
    8
    8
    9
    8
    Completed
    8
    8
    9
    8
    Period 2
    Period 2 title
    Time Point 1 - 48 hours
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was administered centrally by NCTU secure web-based system. Patients were randomised on a 1:1:1:1 basis using a block stratified method (stratified by site) to receive either (1) ondansetron + placebo, (2) metoclopramide + placebo, (3) metoclopramide + ondansetron or (4) double placebo. Assignment to either arm was blinded to both participants and site staff including the PI. IMPs were manufactured and packaged to ensure participants and study staff were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ondansetron plus placebo
    Arm description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Arm title
    		 Metoclopramide plus placebo
    Arm description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metoclopramide plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Arm title
    		 Ondansetron plus Metoclopramide
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus Metoclopramide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Arm title
    		 Double placebo
    Arm description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Double Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Number of subjects in period 2
    		Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Started
    8
    8
    9
    8
    Completed
    8
    7
    9
    8
    Not completed
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    1
    -
    -
    Period 3
    Period 3 title
    Time Point 2 - 5 days
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was administered centrally by NCTU secure web-based system. Patients were randomised on a 1:1:1:1 basis using a block stratified method (stratified by site) to receive either (1) ondansetron + placebo, (2) metoclopramide + placebo, (3) metoclopramide + ondansetron or (4) double placebo. Assignment to either arm was blinded to both participants and site staff including the PI. IMPs were manufactured and packaged to ensure participants and study staff were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ondansetron plus placebo
    Arm description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron PO 4mg tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Arm title
    		 Metoclopramide plus placebo
    Arm description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metoclopramide plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Arm title
    		 Ondansetron plus Metoclopramide
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus Metoclopramide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Arm title
    		 Double placebo
    Arm description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Double Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Number of subjects in period 3
    		Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Started
    8
    7
    9
    8
    Completed
    8
    7
    9
    8
    Period 4
    Period 4 title
    Time Point 3 - 10 days
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was administered centrally by NCTU secure web-based system. Patients were randomised on a 1:1:1:1 basis using a block stratified method (stratified by site) to receive either (1) ondansetron + placebo, (2) metoclopramide + placebo, (3) metoclopramide + ondansetron or (4) double placebo. Assignment to either arm was blinded to both participants and site staff including the PI. IMPs were manufactured and packaged to ensure participants and study staff were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ondansetron plus placebo
    Arm description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron PO 4mg tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Arm title
    		 Metoclopramide plus placebo
    Arm description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metoclopramide plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Film-coated tablet, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Arm title
    		 Ondansetron plus Metoclopramide
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus Metoclopramide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Arm title
    		 Double placebo
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Double placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Oral ondansetron - 4mg given three times daily + placebo Intravenous ondansetron - 4mg given three times daily + placebo

    Number of subjects in period 4
    		Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Started
    8
    7
    9
    8
    Completed
    8
    7
    9
    8
    Period 5
    Period 5 title
    Follow up after delivery
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was administered centrally by NCTU secure web-based system. Patients were randomised on a 1:1:1:1 basis using a block stratified method (stratified by site) to receive either (1) ondansetron + placebo, (2) metoclopramide + placebo, (3) metoclopramide + ondansetron or (4) double placebo. Assignment to either arm was blinded to both participants and site staff including the PI. IMPs were manufactured and packaged to ensure participants and study staff were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ondansetron plus placebo
    Arm description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron PO 4mg tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Arm title
    		 Metoclopramide plus placebo
    Arm description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metoclopramide plus placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Tablet, Film-coated tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Arm title
    		 Ondansetron plus Metoclopramide
    Arm description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ondansetron plus Metoclopramide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Arm title
    		 Double placebo
    Arm description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    Double Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Tablet, Film-coated tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Number of subjects in period 5
    		Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Started
    8
    7
    9
    8
    Completed
    8
    6
    9
    8
    Not completed
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Reporting group values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo Total
    Number of subjects
    		 8 8 9 8 33
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8 9 8 33
    Age continuous
    age at time of recruitment
    Units: years
        median (full range (min-max))
    		 34 (21 to 38) 27 (18 to 34) 27 (21 to 38) 24 (18 to 32) -
    Gender categorical
    Units: Subjects
        Male
    		 0 0 0 0 0
        Female
    		 8 8 9 8 33
    Ethnicity
    Units: Subjects
        White British
    		 6 6 8 6 26
        White Irish
    		 0 1 0 0 1
        Mixed white and black carribean
    		 0 0 0 1 1
        Pakistani
    		 1 0 0 1 2
        Any other Asian background
    		 0 0 1 0 1
        Indian
    		 1 0 0 0 1
        Mixed White and Asian
    		 0 1 0 0 1
    Multiple Birth in current pregnancy
    Units: Subjects
        Yes
    		 1 1 1 0 3
        No
    		 7 7 8 8 30
    Previous use of prochlorperazine for current NVP
    Units: Subjects
        Prochlorperazine
    		 3 2 4 4 13
        not used
    		 5 6 5 4 20
    Gravida
    Units: Subjects
        Gravida 1
    		 1 3 3 5 12
        Gravida 2
    		 3 1 4 0 8
        Gravida 3
    		 0 2 1 0 3
        Gravida 4
    		 1 2 0 2 5
        Gravida 5+
    		 3 0 1 1 5
    Parity
    Units: Subjects
        Parity 0
    		 1 4 4 6 15
        Parity 1
    		 4 2 4 1 11
        Parity 2
    		 0 2 0 1 3
        Parity 3
    		 3 0 1 0 4
    Previous use of cyclizine for current NVP
    Units: Subjects
        Cyclizine
    		 7 7 7 5 26
        not used
    		 1 1 2 3 7
    Previous use of promethazine for current NVP
    Units: Subjects
        Promethazine
    		 1 0 3 1 5
        not used
    		 7 8 6 7 28
    Gestation (in weeks) at randomisation
    Units: weeks
        median (full range (min-max))
    		 8.9 (7.9 to 16.3) 7.9 (6.7 to 13.4) 7.9 (5 to 12.7) 9.6 (6.7 to 15.7) -
    PUQE score
    Participant reported symptom severity scores at baseline via the PUQE questionnaire (Pregnancy Unique Quantification of Emesis)
    Units: total score
        median (full range (min-max))
    		 14 (10 to 15) 11 (8 to 15) 13 (10 to 15) 14 (7 to 15) -
    NVPQOL score
    Participant reported symptom severity scores at baseline via the NVPQOL questionnaire (Nausea and vomiting in pregnancy, quality of life questionnaire)
    Units: total score
        median (full range (min-max))
    		 186 (168 to 203) 178 (165 to 189) 186 (136 to 205) 182 (132 to 206) -
    EPDS score
    Participant reported symptoms of depression and anxiety at baseline via the EPDS questionnaire (Edinburgh Post-natal Depression Scale)
    Units: total score
        median (full range (min-max))
    		 17 (4 to 26) 14 (4 to 21) 14 (3 to 20) 10 (5 to 17) -
    STAI Score
    Participant reported symptoms of depression and anxiety at baseline via the STAI questionnaire (Spielberger State-Trait Anxiety Inventory - short questionnaire)
    Units: total score
        median (full range (min-max))
    		 15 (12 to 23) 17 (9 to 20) 14 (6 to 24) 13 (8 to 19) -
    MSSS Score
    Participant reported maternal social support at baseline via completion of the MSSS questionnaire (maternal social support scale )
    Units: total score
        median (full range (min-max))
    		 29 (27 to 30) 29 (25 to 30) 30 (27 to 30) 29 (25 to 30) -

    End points

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    End points reporting groups
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Primary: number of participants experiencing a treatment failure

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    End point title
    		 number of participants experiencing a treatment failure [1]
    End point description
    The primary endpoint was the number of participants experiencing a treatment failure. Treatment failure was defined as the need for further treatment as a participant’s symptoms had worsened between 12 hours and 10 days post treatment. Where further treatment was required a participant was placed on third line antiemetic treatment (i.e. high dose ondansetron or corticosteroids) unless the clinician considered further second line treatment more appropriate.
    End point type
    Primary
    End point timeframe
    between 12 hours and 10 days post study treatment commencing
    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: As the trial did not progress past the internal pilot due to low numbers recruited, no formal statistical analyses were performed and descriptive analysis only was used.
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    8
    7
    9
    8
    Units: number
        Yes
    2
    4
    4
    5
        No
    6
    3
    4
    2
        Not assessable
    0
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Participant reported symptom severity

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    End point title
    		 Participant reported symptom severity
    End point description
    The PUQE score was used to assess severity of symptoms. The scale quantifies the amount of nausea, vomiting and retching experienced over the previous 24 hours. The PUQE score was collected as part of the study at 48 hours, 5 days and 10 days post treatment commencing. Data from these timepoints is reported in this section.
    End point type
    Secondary
    End point timeframe
    collected between baseline and 10 days post treatment commencing
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    6
    6
    7
    5
    6
    5
    7
    4
    5
    3
    5
    2
    Units: Total score
        median (full range (min-max))
    5 (3 to 13)
    9 (3 to 13)
    7 (3 to 11)
    8 (3 to 12)
    7 (3 to 13)
    7 (5 to 8)
    7 (3 to 11)
    8 (4 to 15)
    8 (3 to 14)
    7 (6 to 9)
    5 (3 to 9)
    6 (3 to 9)
    No statistical analyses for this end point

    Secondary: Participant reported severity of nausea

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    End point title
    		 Participant reported severity of nausea
    End point description
    A visual analogue score (VAS) for nausea was used alongside the PUQE symptoms severity score to examine more subtle changes in nausea. The VAS asked participants to rate, on a scale of 0-10 where 10 was the worst possible nausea you could feel, how bad their nausea was now. The VAS score was collected as part of the study at 48 hours, 5 days and 10 days post treatment commencing. Data from these timepoints is reported in this section.
    End point type
    Secondary
    End point timeframe
    collected 10 days post treatment commencing
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    7
    6
    7
    5
    6
    5
    7
    4
    5
    3
    5
    2
    Units: total score
        median (full range (min-max))
    0 (0 to 8)
    6 (0 to 9)
    3 (0 to 8)
    5 (0 to 6)
    5 (0 to 9)
    5 (1 to 5)
    6 (0 to 10)
    4 (2 to 7)
    5 (0 to 7)
    4 (3 to 8)
    1 (0 to 9)
    2 (0 to 3)
    No statistical analyses for this end point

    Secondary: Quality of Life

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    End point title
    		 Quality of Life
    End point description
    The Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) provided a total score and 4 domain scores (physical symptoms and aggravating factors; fatigue; emotions; limitations). The NVPQOL was collected 10 days post treatment commencing. Data from this timepoint is reported in this section. Of primary interest was the total NVPQOL score which is reported here.
    End point type
    Secondary
    End point timeframe
    collected at baseline and again at day 10
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    4
    3
    5
    2
    Units: total score
        median (full range (min-max))
    160 (88 to 196)
    148 (88 to 175)
    155 (40 to 170)
    105 (81 to 128)
    No statistical analyses for this end point

    Secondary: Anxiety

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    End point title
    		 Anxiety
    End point description
    This parameter was measured using the following scale validated for use in pregnancy: - State Trait Anxiety Inventory [STAI] STAI score data was collected at 10 days. Data from this timepoint is reported in this section.
    End point type
    Secondary
    End point timeframe
    collected at baseline and day 10
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    5
    3
    6
    2
    Units: total score
        median (full range (min-max))
    16 (6 to 24)
    15 (13 to 21)
    14.5 (6 to 22)
    9 (6 to 12)
    No statistical analyses for this end point

    Secondary: Depression

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    End point title
    		 Depression
    End point description
    This parameter was measured using the following scale validated for use in pregnancy: - Edinburgh Post-natal Depression Scale (EPDS) [19]. Data was collected as the total EPDS score (depression) at 10 days. Data from this timepoint is reported in this section.
    End point type
    Secondary
    End point timeframe
    collected at baseline and day 10
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    5
    3
    5
    2
    Units: total score
        median (full range (min-max))
    14 (3 to 18)
    12 (11 to 22)
    13 (10 to 22)
    8 (5 to 11)
    No statistical analyses for this end point

    Secondary: Clinical indicators of anti-emetic effectiveness - relapse at Day 5

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    End point title
    		 Clinical indicators of anti-emetic effectiveness - relapse at Day 5
    End point description
    Defined as a PUQE score ≤ 6 at 48 hours followed by an increase to > 12 at 5 days.
    End point type
    Secondary
    End point timeframe
    collected 5 days post starting trial medication
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    6
    5
    7
    4
    Units: number
        Yes
    0
    0
    0
    0
        No
    6
    5
    7
    4
    No statistical analyses for this end point

    Secondary: Pregnancy outcome

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    End point title
    		 Pregnancy outcome
    End point description
    pregnancy outcome
    End point type
    Secondary
    End point timeframe
    collected via final follow up (via chart review by site team) after delivery of baby
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    8
    6
    9
    8
    Units: number
        Liveborn
    7
    6
    8
    7
        Termination for fetal abnormality
    1
    0
    0
    0
        Termination for other reasons
    0
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Clinical indicators of anti-emetic effectiveness - Relapse at Day 10

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    End point title
    		 Clinical indicators of anti-emetic effectiveness - Relapse at Day 10
    End point description
    Defined as a PUQE score ≤ 6 at 48 hours followed by an increase to > 12 at 10 days.
    End point type
    Secondary
    End point timeframe
    collected 10 days post starting trial medication
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    5
    3
    5
    2
    Units: number
        Yes
    0
    0
    0
    0
        No
    5
    3
    5
    2
    No statistical analyses for this end point

    Secondary: Clinical indicators of anti-emetic effectiveness - Remission at Day 10

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    End point title
    		 Clinical indicators of anti-emetic effectiveness - Remission at Day 10
    End point description
    Defined as a PUQE score ≤ 6 at 48 hours with return to persistent symptoms [PUQE score ≥7] at 10 days. For clarification the definition of remission in this instance is the number of patients whose symptoms had improved by 48h (PUQE≤6) but they then returned to having moderate or severe symptoms (PUQE≥7) by Day 10.
    End point type
    Secondary
    End point timeframe
    assessed 10 days post starting trial medication
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    5
    3
    5
    2
    Units: number
        Yes
    1
    0
    1
    0
        No
    4
    3
    4
    2
    No statistical analyses for this end point

    Secondary: Neonatal Outcomes

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    End point title
    		 Neonatal Outcomes
    End point description
    Information on congenital anomalies detected prior to discharge were collected by the research teams at site via review of participant medical records. In the case of multiple births, this information was collected for each infant.
    End point type
    Secondary
    End point timeframe
    collected via final follow up after delivery of baby
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    8
    6
    9
    8
    Units: number
        Congenital Abnormality Recorded
    0
    0
    0
    1
        No congenital abnormality recorded
    8
    6
    9
    7
    No statistical analyses for this end point

    Secondary: Clinical indicators of anti-emetic effectiveness - number of participants experiencing a treatment failure at 48 hours

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    End point title
    		 Clinical indicators of anti-emetic effectiveness - number of participants experiencing a treatment failure at 48 hours
    End point description
    End point type
    Secondary
    End point timeframe
    between 12 hours and 48 hours post study treatment commencing
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    8
    7
    8
    7
    Units: number
        Yes
    0
    1
    1
    1
        No
    8
    6
    7
    6
    No statistical analyses for this end point

    Secondary: Clinical indicators of anti-emetic effectiveness - readmission rate

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    End point title
    		 Clinical indicators of anti-emetic effectiveness - readmission rate
    End point description
    End point type
    Secondary
    End point timeframe
    the number of participants readmitted with NVP within 10 days of recruitment
    End point values
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double placebo
    Number of subjects analysed
    8
    6
    9
    8
    Units: number
        Yes - readmitted
    2
    2
    4
    1
        No - not readmitted
    6
    4
    5
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) and adverse reactions (ARs) occurring from start of administration of IMP through to 24 hours post last IMP dose were recorded. Symptoms which were present at baseline and did not worsen were not recorded in the eCRF.
    Adverse event reporting additional description
    Adverse events were coded using the MedDRA dictionary and are presented by preferred term, grouped by system organ class.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Ondansetron plus placebo
    Reporting group description
    		 ondansetron 4mg IV three times a day and placebo to match metoclopramide IV three times a day followed by ondansetron 4mg PO tablets three times a day and placebo to match metoclopramide PO tablets three times a day

    Reporting group title
    Metoclopramide plus placebo
    Reporting group description
    		 metoclopramide 10mg IV three times a day and placebo to match ondansetron IV three times a day followed by metoclopramide PO 10mg tablets three times a day and placebo to match ondansetron PO tablets three times a day

    Reporting group title
    Ondansetron plus Metoclopramide
    Reporting group description
    		 ondansetron 4mg IV three times a day and metoclopramide 10mg IV three times a day followed by ondansetron 4mg PO tablets three times a day and metoclopramide 10mg PO tablets three times a day

    Reporting group title
    Double Placebo
    Reporting group description
    		 placebo to match ondansetron IV and placebo to match metoclopramide IV followed by placebo to match ondansetron PO tablets and placebo to match metoclopramide PO tablets

    Serious adverse events
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Termination of Pregnancy due to abnormalities
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Right Calf Deep Vein Thrombosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Incidental paronychia whilst recruiting for EMPOWER.
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ondansetron plus placebo Metoclopramide plus placebo Ondansetron plus Metoclopramide Double Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    3 / 8 (37.50%)
    3 / 9 (33.33%)
    1 / 8 (12.50%)
    Vascular disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nervous system disorders
    Headaches
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Oral candidiasis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Swollen tongue
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    anxiety
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nightmare
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Feeling funny in legs
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2017
    Protocol updated based on advice from the TSC regarding further treatment options for those who fail EMPOWER treatment – clarification provided regarding eligibility criteria – administrative updates
    26 Feb 2018
    Protocol updated to clarify that the PUQE questionnaire could be collected after consent for sites where the PUQE is not routinely collected on admission
    12 Sep 2018
    Protocol updated to include staff participants in qualitative interviews
    13 Nov 2018
    - Protocol updated to reflect extension of the internal pilot phase - Update to the eligibility criteria to include women who had received suboptimal treatment with ondansetron or metoclopramide based on findings during the pilot phase at that point - Minor administrative changes/correction of typos
    25 Feb 2019
    Protocol updated regarding the following: - Update to exclusion criteria amended in last update to provide clarity following feedback from sites from. - Addition of foot note to above mention amendment criteria to be provide clarification regarding intramuscular formulation. - Option provided to collect PUQE, VAS and Health Utilisation Questionnaire via phone at day 10 (other questionnaires still be completed by patient in booklet and returned). - Update title of “Participant Resource Use Questionnaire” in the protocol to “Health Care Utilisation Questionnaire” and “Contingent valuation survey” in protocol to ‘Willingness to Pay’ to match Questionnaire booklet. - Clarification added that participants should have been off SSRIs for at least 2 weeks to be eligible to take part in EMPOWER

    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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