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    Summary
    EudraCT Number:2017-001651-31
    Sponsor's Protocol Code Number:1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-001651-31
    A.3Full title of the trial
    EMPOWER: EMesis in Pregnancy - Ondansetron With mEtoclopRamide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    What improves the symptoms of nausea and vomiting in pregnancy better alongside IV rehydration: ondansetron vs placebo or metoclopramide vs placebo?
    A.3.2Name or abbreviated title of the trial where available
    EMPOWER
    A.4.1Sponsor's protocol code number1.0
    A.5.4Other Identifiers
    Name:Sponsor ReferenceNumber:8367
    Name:Funder ReferenceNumber:16/12/03
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNewcastle upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR: HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewcastle University Clinical Trials Unit
    B.5.2Functional name of contact pointNicola Goudie
    B.5.3 Address:
    B.5.3.1Street Address1-4 Claremont Terrace
    B.5.3.2Town/ cityNewcastle upon Tyne
    B.5.3.3Post codeNE2 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01912087187
    B.5.6E-mailnicola.goudie@newcastle.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metoclopramide MCP-ratiopharm® SF 10 mg / 2 ml injection solution
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetoclopramide MCP-ratiopharm® SF 10 mg / 2 ml injection solution
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMetoclopramide
    D.3.9.1CAS number 364-62-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metoclopramide 10mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetoclopramide 10mg Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMetoclopramide
    D.3.9.1CAS number 364-62-5
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ondansetron 2mg/ml Solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderHameln Pharma Plus gmbh
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOndansetron 2mg/ml Solution for injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOndansetron
    D.3.9.1CAS number 99614-02-5
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ondansetron 4mg Film-Coated Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderWockhardt UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOndansetron 4mg Film-Coated Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOndansetron
    D.3.9.1CAS number 99614-02-5
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIn vitro use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nausea and Vomiting in pregnancy
    Hyperemesis gravidarum
    E.1.1.1Medical condition in easily understood language
    Severe nausea and vomiting in pregnancy.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    The inclusion criteria for the EMPOWER study are as follows:

    • Pregnant women suffering from severe NVP
    • Gestation ≤16 6/7 weeks (16 weeks 6 days)
    • Taken first line antiemetic treatment (cyclize, chlorpromazine, promethazine or prochlorperazine as recommended by the RCOG [10]), as prescribed i.e. full course taken by participant in the current pregnancy with no sustained improvement in symptoms (over a minimum of 24 hours use)
    • Age ≥18 years
    • Able to give informed consent
    • Able to read/understand written English
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The exclusion criteria for the EMPOWER study are as follows:

    • Allergy/hypersensitivity to any of the study drugs
    • Prior treatment with the study drugs in this pregnancy
    • Pre-existing diagnosis of medical condition: type 1 and 2 diabetes, chronic kidney disease (CKD) stage 3-5, Graves’ disease, significant cardiac disease (including long QT syndrome), phaeochromocytoma, epilepsy (or other seizure disorder).
    • Moderate renal impairment (known CKD 3b/4/5 or Cr > 100 in pregnancy)
    • Severe liver impairment (ALT / AST > 150)
    • Severe diarrhoea (definition >10 loose, watery stools in a day (24 hours))*
    • Hypokalaemia**
    • Vomiting caused by another underlying condition/infection
    • Concomitant use of apomorphine, serotonergic drugs (e.g. selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, lithium)

    *If a woman who has severe diarrhoea (as defined above) meets other inclusion criteria and is subsequently found to have a serum potassium > 3 mmol/L and has not yet been prescribed an antiemetic it would be reasonable to offer participation in EMPOWER.

    **all women with severe NVP will have routine assessment of 'Urea & Electrolytes' - in the absence of severe diarrhoea women can be approached, consented and given study treatments before results are available. If the serum potassium is subsequently found to be low (<3 mmol/L) they should not be withdrawn from the trial but the hypokalaemia corrected quickly with intravenous supplementation.
    E.4Principal exclusion criteria
    The exclusion criteria for the EMPOWER study are as follows:

    • Allergy/hypersensitivity to any of the study drugs
    • Prior treatment with the study drugs in this pregnancy
    • Pre-existing diagnosis of medical condition: type 1 and 2 diabetes, Chronic kidney disease (CKD) stage 3-5, Graves’ disease, significant cardiac disease (including long QT syndrome), phaeochromocytoma, epilepsy (or other seizure disorder).
    • Moderate renal impairment (known CKD 3b/4/5 or Cr > 100 in pregnancy)
    • Severe liver impairment (ALT / AST > 150)
    • Severe diarrhoea (definition >10 loose, watery stools in a day (24 hours))*
    • Hypokalaemia**
    • Vomiting caused by another underlying condition/infection
    • Concomitant use of apomorphine, serotonergic drugs (e.g. selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, lithium)

    *If a woman who has severe diarrhoea (as defined above) meets other inclusion criteria and is subsequently found to have a serum potassium > 3 mmol/L and has not yet been prescribed an antiemetic it would be reasonable to offer participation in EMPOWER.

    **all women with severe NVP will have routine assessment of 'Urea & Electrolytes' - in the absence of severe diarrhoea women can be approached, consented and given study treatments before results are available. If the serum potassium is subsequently found to be low (<3 mmol/L) they should not be withdrawn from the trial but the hypokalaemia corrected quickly with intravenous supplementation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of participants experiencing a treatment failure. Treatment failure is defined as the need for further treatment as a participant’s symptoms have worsened between 12 hours and 10 days post treatment initiation. If further treatment is required a participant should be placed on a third line antiemetic treatment i.e. high dose ondansetron or corticosteroids. Participants cannot be given metoclopramide or low dose ondansetron as third line antiemetic treatment initiation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoints of this evaluation are between 12 hours and 10 days post treatment.
    E.5.2Secondary end point(s)
    The secondary endpoints for the EMPOWER study are as follows:

    Participant reported symptom severity: The PUQE score will be 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 will be collected at baseline, 48 hours, 5 days and 10 days post treatment commencing.

    Participant reported severity of nausea: We will use a visual analogue score (VAS) for nausea alongside the PUQE symptoms severity score to examine more subtle changes in nausea. The VAS asks participants to rate, on a scale of 0-10 where 10 is the worst possible nausea you could feel, how bad their nausea is now. The VAS score will be collected at baseline, 48 hours, 5 days and 10 days post treatment commencing.

    NVPQOL: The Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) provides a total score and those in 4 domains (physical symptoms and aggravating factors; fatigue; emotions; limitations). The NVPQOL will be collected at baseline and 10 days post treatment commencing. Of primary interest will be the total NVPQOL score.

    Anxiety, depression and social support: These parameters will be measured using the following scales which are validated for use in pregnancy:
    Edinburgh Post-natal Depression Scale (EPDS).
    State Trait Anxiety Inventory [STAI]:
    Maternity Social Support scale:
    Data will be collected as the total EPDS score (depression) and total STAI score (anxiety) at baseline and 10 days. The total maternal social support scale score will be reported at baseline.

    Clinical indicators of anti-emetic effectiveness
    (a) The number of participants experiencing a treatment failure (as per primary endpoint) at 48 hours
    (b) Relapse rate at 5 and 10 days (defined as a PUQE score of ≤ 6 at 48 hours followed by an increase to > 12 at 5 / 10 days)
    (c) Remission rate at 10 days (defined as a PUQE score of ≤ 6 at 48 hours with return to persistent symptoms [PUQE score 7-12] at 10 days)
    (d) Readmission rates (the number of participants readmitted with NVP within 10 days of recruitment and between 10 days of recruitment and 20 weeks of pregnancy)
    (e) Total in-patient days related to NVP between recruitment and 20 weeks of pregnancy and between 20 weeks of pregnancy and delivery
    (f) Additional antiemetic use

    Side effects and adverse events: Participants will be asked about the occurrence of the most common side effects of each drug identified from previous research. Those indicating the presence of a specific side effect will be asked to grade severity using the Common Terminology Criteria for Adverse Events (CTCAE). Participants will also be asked about any other suspected adverse events. Adverse events will be reported by grade (including no occurrence for pre-specified side effects) at 48 hours, 5 days and 10 days and as the worst grade reported over the 10 day period.

    Pregnancy and neonatal outcomes: The number of women reporting miscarriage, termination of pregnancy and stillbirth will be reported. For each infant born, the mode of delivery, gestational age at delivery, birth weight and number of infants born small for gestational age (SGA) will also be reported. SGA refers to an infant born with a birth weight less than the 10th centile, customised for maternal characteristics (maternal height, weight, parity and ethnic group) as well as gestational age at delivery and infant sex. Information on congenital anomalies detected prior to discharge will be collected by the research teams at site via review of participant medical records and provided to the UK Teratology Information Service (UKTIS). In the case of multiple births, this information will be collected for each infant. Participants will also be asked if they would be willing to provide information directly to UKTIS via their Bumps website online reporting tool however this is not mandatory. The participant will use their unique participant trial identifier to provide information and no identifiable data will be collected via the online tool.

    Key economic outcomes (detailed in Economic Analysis section) include: (a) Costs to the NHS, women and their families; (b) Willingness to pay for the benefits of antiemetic treatment; (c) Incremental cost per additional successful treatment and incremental net-benefit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of this evaluation are between baseline and post birth.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As follow-up data will be collected after the participant has delivered end of trial is defined as the date the last infant born is discharged from hospital.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants will take IMP for a maximum of 10 days while in this study. After this it is anticipated that the participant’s NVP symptoms should have subsided. The Participant Information Sheet will advise participants to attend the antenatal unit/maternal assessment unit that they attended as part of the study if NVP symptoms return after they have concluded study treatment...

    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation North East and North Cumbria Clinical Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-02
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