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    Summary
    EudraCT Number:2011-004725-27
    Sponsor's Protocol Code Number:GA1109
    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:2011-12-23
    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 number2011-004725-27
    A.3Full title of the trial
    A single-centre, randomised, double-blind, two-way crossover, placebo-controlled pilot study, investigating the use of a novel intragastric and oesophageal pH catheter to characterise the antacid activity of Gaviscon Double Action Liquid in the fasted state followed by a preliminary investigation of the effects of food.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine the pH produced in the stomach and oesophagus after taking Gaviscon Double Action Liquid Vs Placebo.
    A.3.2Name or abbreviated title of the trial where available
    Pilot Gaviscon Double Action pH monitoring study
    A.4.1Sponsor's protocol code numberGA1109
    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) Ltd
    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) lTD
    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) Ltd
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressDansom Lane
    B.5.3.2Town/ cityHull
    B.5.3.3Post codeHU8 7DS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441482582040
    B.5.5Fax number441482582172
    B.5.6E-mailjoanne.wilkinson@reckittbenckiser.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser Healthcare (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 nameGaviscon Double Action Liquid
    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.3.9.3Other 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 number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM BICARBONATE
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive nameSODIUM BICARBONATE
    D.3.9.4EV Substance CodeSUB12643MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number213
    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 number375
    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
    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 novel pH catheter for the measurement of oesophageal and intragastric pH comparing the onset and duration of antacid action of Gaviscon Double Action versus placebo.
    E.1.1.1Medical condition in easily understood language
    Study to determine the pH produced in the stomach and oesophagus after taking Gaviscon Double Action Liquid 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
    The primary objective of the study is to pilot the use of a novel pH catheter for the measurement of oesophageal and intragastric pH comparing the onset and duration of antacid action of Gaviscon Double Action versus placebo. This study has been designed to develop appropriate endpoints for future studies.
    E.2.2Secondary objectives of the trial
    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) Those who are willing to volunteer and have provided written informed consent
    2) Age: ≥ 18 years, ≤ 50 years
    3) Sex: male or female subjects
    4) Status: healthy subjects
    5) Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre
    E.4Principal exclusion criteria
    Subjects to whom any of the following conditions apply must be excluded:
    1) Those who have a history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
    2) Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.
    3) Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery.
    4) Those who have been hospitalised within the previous three months for major surgery or medical illness.
    5) Those who have had a clinically significant illness within the previous four weeks.
    6) Those who 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) Those who have taken antacids, H2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study
    8) Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study.
    9) Those who have a drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study.
    10) Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents
    11) Those who consume abnormal quantities of coffee, tea or cola (e.g. more than three cups) according to the Principal Investigator’s judgement or consume alcohol regularly.
    12) Those who have taken part in any clinical study within the previous four months, or have taken part in a total of four or more studies in the last 12 months.
    13) Those who are unable to communicate well with the Chief Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Chief Investigator
    14) Those who have evidence of columnar lined oesophagus (as determined during the endoscopy procedure to place the catheter).
    15) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
    16) Those previously randomised into this study.
    17) 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 assessment of electrode 6 at 1 minute intervals post dose. The primary analyses will be a comparison of the pH values for Gaviscon Double Action versus placebo from the smoothed pH curve at electrode 6 at each 1 minute interval up to four hours post-dose during the fasted state.
    If the 4 second intervals at which the pH is captured do not match with the end of a 1 minute interval since dosing, linear interpolation will be used between values either side of the smoothed pH curve.
    E.5.2Secondary end point(s)
    • Comparison of the pH values for Gaviscon Double Action versus placebo from the smoothed pH curve at all other electrodes at each 1 minute interval up to four hours post-dose during the fasted state. If the 4 second intervals at which the pH is captured do not match with the end of a 1 minute interval since dosing, linear interpolation will be used between values either side of the smoothed pH curve.
    • Time to reach pH 3 on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo
    • Time to reach pH 4 on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo.
    • Duration of time at which ≥ pH 3 is maintained on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo.
    • Duration of time at which ≥ pH 4 is maintained on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo.
    • Change in pH on the smoothed curve at electrode 1 over time for Gaviscon Double Action versus placebo.
    • Change in pH on the smoothed curve at electrode 2 over time for Gaviscon Double Action versus placebo.

    As this is a pilot study further exploratory analysis of the data may also occur to develop other relevant endpoints for future studies.
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A single-centre, randomised, double-blind, two-way crossover, placebo-controlled pilot study.
    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.8.3 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
    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: 14
    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 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 state14
    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 will return to ICON CPU for a Post Study Follow-up Visit 3 to 7 days after Day 2 of Treatment Period 2.They will be asked if they have experienced any symptoms or complaints since their last visit, and if they have taken any medication. Subjects’ vital signs will be recorded and they will undergo a physical examination. A blood sample will be taken for haematology and biochemistry tests and a urine sample will be collected for urinalysis, as described in the protocol.
    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 Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-24
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