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    Summary
    EudraCT Number:2019-003220-21
    Sponsor's Protocol Code Number:GA19/105668
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-12-12
    Trial 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 number2019-003220-21
    A.3Full title of the trial
    Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE.
    A.3.2Name or abbreviated title of the trial where available
    MODULATE
    A.4.1Sponsor's protocol code numberGA19/105668
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN16086699
    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 SponsorUniversity of Leeds
    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 - Health Technology Assessment (HTA) Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeeds Institute of Clinical Trials Research, University of Leeds
    B.5.2Functional name of contact pointAmy West
    B.5.3 Address:
    B.5.3.1Street AddressCTRU, University of Leeds
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS2 9JT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0113 343 4802
    B.5.6E-mailmodulate@leeds.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 Information not present in EudraCT
    D.2.1.1.1Trade name Amitriptyline
    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 nameAmitriptyline
    D.3.4Pharmaceutical form Film-coated 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 INNAmitriptyline hydrochloride
    D.3.9.1CAS number 549-18-8
    D.3.9.4EV Substance CodeAS1
    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: 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 Information not present in EudraCT
    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
    D.3.4Pharmaceutical form Film-coated 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 hydrochloride dihydrate
    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 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.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 Information not present in EudraCT
    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 nameLoperamide
    D.3.4Pharmaceutical form
    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 INNloperamide hydrochloride
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diarrhoea in patients with stable ulcerative colitis.
    E.1.1.1Medical condition in easily understood language
    Diarrhoea in patients with stable ulcerative colitis .
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10033007
    E.1.2Term Other ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066557
    E.1.2Term Chronic diarrhoea
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our primary objectives are to answer the following questions:

    1. At phase 2: What is the short-term effectiveness of a low FODMAP diet, low-dose amitriptyline, ondansetron, and loperamide, each compared with a control of standard first-line dietary advice, in terms of improvement in diarrhoea, via the diarrhoea subscale of the gastrointestinal symptom rating scale-IBS (GSRS-IBS) at 8 weeks, defined as reporting minor discomfort (score ≤2) from diarrhoea or less.

    2. At phase 3: What is the effectiveness of a maximum of two interventions continued from phase 2 (having shown evidence of short-term effectiveness) in terms of improved disease-specific quality of life, via the inflammatory bowel disease questionnaire (IBDQ), at 6 months?
    E.2.2Secondary objectives of the trial
    Our secondary objectives are to answer the following questions at both 8 weeks and 6 months:

    1. What is the effect of the active treatments, compared with a control of standard first-line dietary advice, in terms of:

    a. Improvement in discomfort from loose stools, via the GSRS-IBS?

    b. Improvement in discomfort from diarrhoea, urgency, and abdominal pain, via the GSRS-IBS?

    c. Markers of disease activity, including escalation of medical therapy, need for surgery, faecal calprotectin, and C-reactive protein?

    d. Mood, via the hospital anxiety and depression scale?

    2. What is the tolerability and safety of the active treatments, compared with a control of standard first-line dietary advice, including rates of constipation and numbers of patients with a flare of disease activity?

    3. What is the adherence to each of the active treatments, compared with a control of standard first-line dietary advice?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A histological diagnosis of UC in secondary care, including left-sided colitis or extensive colitis.
    2. Age ≥18 years.
    3. At least moderate discomfort from diarrhoea according to the GSRS-IBS [26] (equating to a score of ≥4 on the diarrhoea subscale of the GSRS-IBS)
    4. On stable doses of UC-related medication for ≥2 months at time of initial screening telephone call.
    5. Ongoing diarrhoea for 3 months prior to initial screening telephone call.
    6. A CRP <5mg/L (measured as per local practise) within 4 weeks prior to randomisation.
    7. FC <250mcg/g [29] within 4 weeks prior to randomisation.
    8. Stable UC at the time of randomisation, in the clinical opinion of the gastroenterologist1,
    9. No evidence of active suicidal ideation at time of initial screening telephone call and prior to randomisation, as determined by the three clinical screening questions below2:
    a. Whether the patient has experienced any thoughts of harming themselves, or ending their life in the last 7-10 days?
    b. Whether the patient currently has any thoughts of harming themselves or ending their life?
    c. Whether the patient has any active plans or ideas about harming themselves, or taking their life, in the near future?
    10. No recent history of self-reported self-harm (an episode of self-harm within the last 12 months).
    11. Willing to be considered for all treatment arms of the trial, and to remain in the treatment arm to which they are assigned.
    12. If female must be:
    a. post-menopausal (no menses for 12 months without an alternative medical cause), or;
    b. surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or;
    c. using highly effective contraception (and must agree to continue for 7 days after the last dose of the investigational medicinal product [IMP]). 3
    13. Able to complete questionnaires and trial assessments.
    14. Able to provide written informed consent.
    E.4Principal exclusion criteria
    1. Inflammatory bowel disease unclassifiable or Crohn’s disease.
    2. Ulcerative proctitis.
    3. Body mass index≤18.5 kg/m2.
    4. Previous or planned gastrointestinal IBD-related resectional surgery or previous cholecystectomy.
    5. Having received steroids for UC within the last 2 months prior to the initial screening telephone call or at randomisation.
    6. Coeliac disease (as confirmed via anti-tissue transglutaminase (tTG) antibodies).
    7. A previous diagnosis of colorectal dysplasia or cancer, or no up to date surveillance colonoscopy, as per current British Society of Gastroenterology guidelines [30].
    8. Known allergy to TCAs, ondansetron, or loperamide.
    9. Current use of a TCA at the time of the initial screening telephone call or at randomisation.
    10. Previous failed treatment with, or regular use of amitriptyline, ondansetron, or loperamide for diarrhoea.
    11. Currently on, or have previously tried and failed, a low FODMAP diet under dietitian guidance.4
    12. Contraindications5 to the current use of TCAs including patients with any of the following:
    a. taking monoamine oxidase inhibitors, or receiving them within the last 2 weeks;
    b. already currently prescribed a TCA for the treatment of depression
    c. previous myocardial infarction;
    d. recorded arrhythmias, particularly heart block of any degree, or prolonged Q-T interval on electrocardiogram;
    e. mania;
    f. severe liver disease;
    g. porphyria;
    h. congestive heart failure;
    i. coronary artery insufficiency;
    j. receiving concomitant drugs that prolong the QT interval (e.g. amiodarone, terfenadine, or sotalol).
    13. Contraindications to the current use of ondansetron, including:
    a. concomitant use of apomorphine;
    b. concomitant use of other drugs that prolong the QT interval.
    14. Contraindications to the current use of loperamide, including:
    a. acute UC;
    b. acute dysentery, which is characterised by blood in stools and high fever;
    c. bacterial enterocolitis caused by invasive organisms;
    d. pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
    15. Pregnancy, planned pregnancy during the study, pregnancy within 3 months of study completion, or breastfeeding6.

    1 A flexible sigmoidoscopy with Mayo score ≤1 is only required if there is clinical uncertainty regarding the stability of the patient’s UC and is at the discretion of the treating physician. Rectal bleeding reported by the patient would contribute to the assessment of disease stability and if present should be assessed by flexible sigmoidoscopy.
    2Suicidal ideation should be assessed on the screening telephone call. No more than 14 days should elapse between the initial suicidal ideation assessment and study entry/ randomisation. If more than 14 days have elapsed then the suicidal ideation assessment should be repeated.
    3Highly effective contraception is defined as one of the following: combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; practising true abstinence ( defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject).
    4Patients currently waiting to see a dietitian for a low FODMAP diet must agree not to commence seeing a dietitian unless they are randomised to the low FODMAP arm of the trial.
    5Cautions to the use of TCAs will not be an exclusion, but these will be recorded at screening and clarified with the patient’s gastroenterologist and the principal investigator (PI) in each centre prior to study entry. These include cardiovascular disease; diabetes; epilepsy; history of psychosis or bipolar disorder; hyperthyroidism; increased intra-ocular pressure; phaeochromocytoma; prostatic hypertrophy (prostate gland enlargement); susceptibility to angle-closure glaucoma; difficulty passing urine.
    6 For women of childbearing potential (those not post-menopausal or surgically sterile) a pregnancy test must be performed within 7 days prior to randomisation. Post-menopausal is defined as no menses for 12 months without an alternative medical cause.
    E.5 End points
    E.5.1Primary end point(s)
    MODULATE follows a multi-arm multi-stage design, with a total of five arms spanning over two phases (phase II and phase III). We therefore have two distinct primary outcome measures that define our phase II and phase III endpoints, at 8 weeks and 6 months, respectively.

    In phase II, our primary objective is to evaluate the short-term effectiveness of the four proposed interventions, against a control, with regard to improvement of diarrhoea symptoms. The primary outcome used to measure this is a single item from the gastrointestinal symptom rating scale-IBS (GSRS-IBS) questionnaire – question 6, which asks patients how much discomfort has been caused by diarrhoea during the past week, administered at 8 weeks post-randomisation. Possible responses to the question are scored on a Likert scale 1 to 7. This outcome will be analysed as a binary endpoint using logistic regression, where improvement is defined as those responding with a score of ≤2 to the diarrhoea question (no discomfort, or minor discomfort).

    In phase III, our primary objective is to evaluate the effectiveness of a maximum of two interventions, against a control, with regard to improvement of disease-specific quality of life, at 6 months post randomisation. The primary outcome used to measure this is the Inflammatory Bowel Disease Questionnaire (IBD-Q), a 32-item questionnaire measuring inflammatory bowel disease (IBD)-specific health-related quality of life. Possible responses to questions in the IBD-Q are scored on a Likert scale of 1 to 7, giving a total score of between 32 and 224, which will be analysed using linear regression methods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase II - 8 weeks

    Phase III - 6 months
    E.5.2Secondary end point(s)
    Our secondary objectives are to answer the following questions at both 8 weeks and 6 months:

    1. What is the effect of the active treatments, compared with a control of standard first-line dietary advice, in terms of:
    a. Improvement in discomfort from loose stools, via the GSRS-IBS?
    b. Improvement in discomfort from diarrhoea, urgency, and abdominal pain, via the GSRS-IBS?
    c. Markers of disease activity, including escalation of medical therapy, need for surgery, faecal calprotectin, and C-reactive protein?
    d. Mood, via the hospital anxiety and depression scale?

    • What is the tolerability and safety of the active treatments, compared with a control of standard first-line dietary advice?

    • What is the adherence to each of the active treatments, compared with a control of standard first-line dietary advice?
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks and 6 months
    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 Yes
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard first line dietary advice
    E.8.2.4Number of treatment arms in the trial5
    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 concerned26
    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
    The end of the trial is defined as the date of the last patient’s last data item.
    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 months7
    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: 417
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state491
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 491
    F.4.2.2In the whole clinical trial 491
    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)
    If participants believe they have had a benefit from the trial treatment, they may wish to continue their treatment off-trial.

    Participants are advised that they may approach their clinician following trial completion for off-trial prescribing of amitriptyline, ondansetron, or loperamide.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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