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    Summary
    EudraCT Number:2019-004561-41
    Sponsor's Protocol Code Number:FGC-19-003
    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:2020-03-23
    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 number2019-004561-41
    A.3Full title of the trial
    The use of Antacids and Alginates during Pre-Investigation Proton Pump Inhibitor Washout: Impact on Compliance and Symptom Burden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PPI-Washout Study
    A.3.2Name or abbreviated title of the trial where available
    PPI-Washout Study
    A.4.1Sponsor's protocol code numberFGC-19-003
    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 SponsorThe Functional Gut Clinic
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Gaviscon Advance
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser Healthcare (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 nameGaviscon Advance
    D.3.4Pharmaceutical form Oral suspension
    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 INNSodium Alginate
    D.3.9.1CAS number 9005-38-3
    D.3.9.4EV Substance CodeAS1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium Hydrogen Carbonate
    D.3.9.1CAS number 298-14-6
    D.3.9.4EV Substance CodeAS2
    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
    Gastro-oesophageal reflux disease
    E.1.1.1Medical condition in easily understood language
    Acid reflux
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066872
    E.1.2Term Acid reflux (esophageal)
    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
    The Gastro-Esophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) (1) score is a validated questionnaire and is commonly used in reflux studies. We will use this questionnaire to ask how patients tolerate stopping their acid reducing medications before reflux testing. We will use this to see if giving them specific instruction about how to use Gaviscon Advance helps patients to tolerate better, versus simply giving them the plain information and allowing them to do it themselves.
    (1) Velanovich, V. The development of the GERD-HRQL symptom severity instrument. Diseases of the Esophagus. Volume 20, Issue 2, P130-134. April 2007.
    E.2.2Secondary objectives of the trial
    We will also use the Gastrointestinal Symptom Score (1) to see if this confirms the finding of the primary question, as well as a questionnaire we have created regarding the patients' adherence to the washout protocol (submitted with additional documents). Sometimes patients know they should stop the medication for the test, but end up taking it anyway as their symptoms are too bad, potentially affecting the results of their test. We will ask the patients to try and truthfully record whether they did manage to stop PPIs or not and reassure them that this information is blinded from the study organisers. In this way we will be able to see if by using the specific instructions we can improve patient’s adherence to the test instructions. The last secondary outcome will be in the measurement of mucosal impedance. At the same time as recording reflux events, the catheter used in the reflux test can take a baseline measurement of mucosal impedance which has been linked to mucosal integrity a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients ≥ 18 years age.
    • Clinical investigation for reflux symptoms (heartburn and/or regurgitation) or dyspepsia (nausea, upper abdominal discomfort, early satiety and/or upper abdominal bloating).
    • Already established on ≥4 weeks of standard or double dose PPI therapy.
    • Clinical requirement for pre-investigation PPI washout period.
    • Is able to communicate well with the study team and comply with the requirements for the entire study.
    • Has the capacity to understand written English.
    E.4Principal exclusion criteria
    • Red flag symptoms or urgent (2 week wait referral).
    • Known Barrett’s oesophagus, reflux oesophagitis, peptic ulcer disease, or upper gastrointestinal malignancy.
    • Other clinical indication for PPI continuation.
    • Previous oesophageal or gastric surgery.
    • Intolerant of alginate preparations.
    • Patients on a low salt diet.
    • Unable to tolerate the nasogastric reflux probe for a minimum of 18 hours.
    • Involvement in any other research currently or within the last four weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in GERD-HRQL score calculated statistically using a paired t-test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Exit of final participant.
    E.5.2Secondary end point(s)
    • Change in gastrointestinal symptom score
    • PPI and H2-receptor antagonist use
    • Mean nocturnal baseline impedance measurement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Exit of final participant.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days29
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state46
    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)
    Once the research is finished patients will be told whether the new protocol was better than the current, such that if patients come for repeat testing, or indeed if they have to stop PPIs in future for any reason, they will be aware of what regimen of antacids/alginates can be of use.
    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 Decision2020-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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