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    Summary
    EudraCT Number:2014-003174-17
    Sponsor's Protocol Code Number:GA1405
    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:2014-10-28
    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 number2014-003174-17
    A.3Full title of the trial
    A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled pivotal study to assess the effect of a sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to PPI treatment – a pivotal study.
    A.3.2Name or abbreviated title of the trial where available
    Sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to PPI
    A.4.1Sponsor's protocol code numberGA1405
    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 SponsorReckitt Benckiser Healthcare (UK) Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportReckitt Benckiser Healthcare (UK) Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReckitt Benckiser Healthcare (UK) Limited
    B.5.2Functional name of contact pointStudy Specific Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressDansom Lane
    B.5.3.2Town/ cityHull
    B.5.3.3Post codeHU87DS
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailGA1405@rb.com
    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 Double Action Liquid Sachets
    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 Double Action Liquid Sachets
    D.3.4Pharmaceutical form Oral suspension in sachet
    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.3.9.3Other descriptive nameSODIUM ALGINATE
    D.3.9.4EV Substance CodeSUB15270MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM HYDROGEN CARBONATE
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive nameSODIUM HYDROGEN CARBONATE
    D.3.9.4EV Substance CodeSUB12290MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21.3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIUM CARBONATE
    D.3.9.1CAS number 471-34-1
    D.3.9.3Other descriptive nameCALCIUM CARBONATE
    D.3.9.4EV Substance CodeSUB13166MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32.5
    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 placeboOral suspension in sachet
    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
    Gastro-Oesophageal Reflux Disease (GORD)
    E.1.1.1Medical condition in easily understood language
    Gastro-Oesophageal Reflux Disease (GORD)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    The primary objective of this study is to assess the efficacy of sodium alginate liquid suspension compared with matched placebo liquid in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the efficacy of sodium alginate liquid suspension compared with matched placebo liquid in change in duration, frequency, severity and timing of the symptoms of heartburn, acid regurgitation and dyspepsia in patients with GORD whose symptoms are inadequately controlled by once daily PPI therapy alone. Other secondary objectives include a comparison of the treatments with respect to patient satisfaction and safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent has been obtained.
    2. Age: Minimum 18 years
    3. Sex: male or female.
    4. Current evidence of symptomatic GORD in accordance with the Montreal definition(5) following treatment with a proton pump inhibitor (as specified in inclusion criteria #6). This evidence can be based solely on symptom characteristics but in the opinion of the Investigator the symptoms are not related to conditions such as irritable bowel syndrome, gall bladder disease or other such conditions that may present themselves as heartburn or regurgitation.
    5. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least 3 days a week during the 2 weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms.
    *Symptom intensity should be assessed using the following scale:
    a. Mild: Awareness of symptom but easily tolerated.
    b. Moderate: Discomforting symptom sufficient to cause interference with normal activities including sleep.
    c. Severe: Incapacitating symptom with inability to perform normal activities, including sleep.
    6. Prescribed treatment with once-daily (before breakfast) PPI for at least the previous 4 weeks at stable standard approved doses, e.g. lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day, 40 mg esomeprazole per day.
    7. Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the Investigator.

    Following the 7-day run-in period, patients will be assessed against the following inclusion criteria before randomisation.
    8.Completion of the run-in diary card and questionnaires on each of the 7 days of the run-in period.
    9.At least 3 days during the 7-day run-in period with a HRDQ score [Heartburn and Regurgitation] >0.7.
    10.Compliance with PPI treatment (once daily in the morning) on all 7 days of the run-in period.
    E.4Principal exclusion criteria
    Patients to whom any of the following conditions apply must be excluded:
    1.Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, recent (within the last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
    2.A recent (previous 3 months) history of drug, solvent or alcohol abuse (weekly alcohol intake ≥140 g or 17.5 units).
    3.Recent (previous 3 months) cardiac chest pain.
    4.Recent (previous 6 months) significant unexplained weight loss of >6 kg in the last 6 months
    5.Gastrointestinal bleeding (lower GI bleeding or haematemesis) within the last 3 months.
    6.Patients who have taken non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) for more than 3 consecutive days in the 28 days prior to screening
    7.Patients who have taken any of the following treatments in the week prior to the screening visit (Visit 1) and who may require any of these during the study (as they are also excluded throughout the study):
    a.H2-receptor antagonists
    b.Anti-cholinesterase drugs, sucralfate or misoprostol preparations
    c.Antacids (including Gaviscon).
    8.Patients taking or needing to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
    9.Current enrolment in another study or involvement in a previous study assessing symptom relief with sodium alginate in the past year.
    10.Previous surgery of the oesophagus, stomach or duodenum.
    11.Any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or interfere with the assessment of efficacy.
    12.Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions, or are unwilling to be sexually abstinent (as defined in Section 10.4).
    13.Pregnancy or lactating mother.
    14.Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
    15.Patients with severe/impaired renal function or insufficiency.
    16.Any previous history of allergy or known intolerance to any of the Investigational Medicinal Product (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), hydrogenated glucose syrup (maltitol), carbomer and xanthan gum.
    17.Previously randomised into the study.
    18.Employee at study site.
    19.Partner or first-degree relative of the Investigator.
    20.Participation in a clinical study in the previous 3 months.
    21.Unable, in the opinion of the Investigator, to comply fully with the study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is whether the patient achieves a reduction of at least 3 days in the number of days with a HRDQ score [Heartburn and Regurgitation]>0.7 during the 7-day treatment period compared to the 7-day run-in period.
    The results between the two groups (sodium alginate liquid suspension vs. matched placebo liquid) will be compared.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7-day treatment period vs 7-day run-in period
    E.5.2Secondary end point(s)
    The following secondary endpoints will be compared between the sodium alginate liquid suspension and matched placebo liquid:

    •Change in the mean daily HRDQ score [Heartburn and Regurgitation] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • •Change in the mean daily frequency/severity of individual symptoms [heartburn and regurgitation taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    •The number of nights with symptoms (taken from HRDQ) during the 7-day treatment period.
    •Whether the patient has any night-time symptoms (taken from HRDQ) during the 7-day treatment period.
    •Change in the mean daily duration of symptoms [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    •The number of symptom-free days (taken from HRDQ) during the 7-day treatment period where patients are free from Heartburn and Regurgitation symptoms.
    •Change from baseline in patient satisfaction scores at the end of the study.
    •Change from baseline in RDQ symptom scores for the GORD dimension (heartburn and regurgitation) after a 7-day treatment period
    •Change in the mean daily score of heartburn and regurgitation [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in) separately.
    •Change from baseline in RDQ scores for the heartburn and regurgitation dimensions separately after a 7-day treatment period.
    •Change from baseline in frequency/severity scores for the heartburn and regurgitation dimensions [taken from RDQ] separately after a 7-day treatment period.

    The daily patient satisfaction score will be assessed against the daily entries in the HRDQ.

    Safety will be assessed in terms of the overall proportion of subjects with adverse events (AEs).

    Exploratory Endpoints

    •Change in the mean daily score of dyspepsia [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    •Change from baseline in the dyspepsia dimension score [taken from RDQ] after a 7-day treatment period.
    •Change from baseline in frequency/severity scores for the dyspepsia dimension [taken from RDQ] after a 7-day treatment period.
    •The number of symptom free days (taken from HRDQ) during the 7-day treatment period where patients are free from Heartburn, Regurgitation and Dyspepsia symptoms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7-day treatment period vs 7-day run-in period
    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 No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 months10
    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 months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 272
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 272
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state136
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 272
    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)
    Patients who experience AEs at the end of the study, or experience the onset of an AE after the end of the study, will be followed up as described in Sections 13.1.7 and 13.1.8.
    No other additional care of study patients will take place following the end of the study. The treatment of the patient’s condition will follow normal clinical practice
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-24
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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