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    Summary
    EudraCT Number:2014-003158-15
    Sponsor's Protocol Code Number:GA1406
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003158-15
    A.3Full title of the trial
    A randomised, assessor blind, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, using a custom-designed intragastric and oesophageal pH catheter.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gaviscon Exploratory pH Monitoring Study
    A.3.2Name or abbreviated title of the trial where available
    Gaviscon Exploratory pH Monitoring Study
    A.4.1Sponsor's protocol code numberGA1406
    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 pointLaura Brown
    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.5.4Telephone number00441480582257
    B.5.6E-mailLaura.Brown@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 Duo sachets, suspensie voor oraal gebruik in sachet
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number426
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number650
    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 Rennie, kauwtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBayer B.V., Energieweg 1, 3641 RT Mijdrecht
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRennie kautabletten
    D.3.4Pharmaceutical form Chewable 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 INNMAGNESIUM CARBONATE
    D.3.9.1CAS number 546-93-0
    D.3.9.3Other descriptive nameMAGNESIUM CARBONATE
    D.3.9.4EV Substance CodeSUB14418MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number680
    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
    To pilot the use of a custom designed pH catheter for the measurement of intragastric pH to characterise the antacid action of Gaviscon Double Action versus placebo.
    E.1.1.1Medical condition in easily understood language
    Study to determine the pH of the acid in the stomach after taking Gaviscon Double Action Vs Placebo.
    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
    To investigate the acid neutralisation action of Gaviscon Double Action Liquid Sachets versus placebo liquid, within the stomach. To assess suitability and robustness of the pH monitoring methodology.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only subjects to whom all of the following conditions apply will be included:
    1) Informed consent has been obtained.
    2) Age: ≥ 18 years ≤ 50 years.
    3) Sex: male or female subjects.
    4) Status: healthy subjects.
    5) Body Mass Index (BMI): ≥ 18.5 and ≤ 24.9.
    E.4Principal exclusion criteria
    Subjects to whom any of the following conditions apply must be excluded:
    1) A history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
    2) Clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.
    3) A history of basal skull fracture or who have undergone trans-sphenoidal surgery.
    4) Have been hospitalised within the previous three months for major surgery or medical illness.
    5) A clinically significant illness within the 4 weeks prior to screening.
    6) Have taken any prescription medication or non-prescription medication within the last seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
    7) Have taken antacids, H2 antagonists, motility stimulants (e.g. prokinetics, macrolide antibiotics such as erythromycin and azithromycin, and 5HT agonists such as sumatriptan) or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study and/or have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study. Enrolment is defined as the date of informed consent signature.
    8) Are taking any of the following medications: antihistamines, tetracyclines, antifungals, digoxin, fluoroquinolone, iron salt, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, and biphosphonates.
    9) Have a drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study.
    10) Any previous history of allergy or known intolerance to any of the Investigational Medicinal Product’s (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer, and xanthan gum
    11) Those with known hypophosphataemia.
    12) Those on a highly restricted salt diet.
    13) Those with, or a history of, hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
    14) A current or recent (within one year) history of alcohol abuse or significant abuse of any legal or illegal drugs, substances and solvents.
    15) Regularly (weekly) consume excessive amounts of alcohol (> 8 units for men and > 6 units for women in one sitting, excessive amounts as defined by the UK National Office of Statistics).
    16) Have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit.
    17) Regular consumption of excessive quantities of caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator’s judgement.
    18) Tobacco use is > 6 cigarettes per day or equivalent or unable to refrain from tobacco/ nicotine use during the study periods.
    19) Any clinically significant abnormal laboratory result, in the opinion of the Principal Investigator.
    20) Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions (as defined in the protocol or are unwilling to be sexually abstinent (as defined in the protocol).
    21) Pregnancy or lactating mother.
    22) Are unable to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator.
    23) Those previously randomised into this study.
    24) Employee at study site.
    25) Partner or first-degree relative of the Investigator.
    26) Participation in a clinical study in the previous 3 months.
    27) Those 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 will be the mean percentage of time that pH ≥ 4 over 0-30 minutes post-dose across electrodes 3 to 10. The primary analysis will be the comparison of this endpoint between Gaviscon Double Action Liquid Sachets versus placebo liquid.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 0-30 minutes post-dose
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • The mean percentage of time that pH ≥ 4 over the interval 30-60 minutes post-dose across electrodes 3 to 10.
    • The mean percentage of time that pH ≥ 3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 3 to 10.
    • The mean percentage of time that pH ≥ 3 and pH ≥ 4 over the 10 minute intervals post-dose across electrodes 3 to 10.
    • The percentage of time that pH ≥ 3 and pH ≥ 4 over the 10 minute and 30 minute intervals at each electrode.
    These endpoints will be compared between Gaviscon Double Action Liquid Sachets and placebo. For calcium carbonate / magnesium carbonate chewable tablets, these endpoints will be assessed non-comparatively.
    For all treatments, the following will be displayed non-comparatively:
    • The pH level at each 4 second time point during each monitoring period at each electrode.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As detailed in E.5.2
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 months3
    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 months3
    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: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state24
    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)
    Subjects 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.
    No other additional care will take place following the end of the study. Study subjects are healthy subjects, so additional care is not appropriate. Should any abnormalities be identified during the endoscopy , then the subject will be referred to their physician for additional examinations and care, if deemed required by the consultant gastroenterologist.
    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 Decision2014-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    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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