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    Summary
    EudraCT Number:2012-000678-44
    Sponsor's Protocol Code Number:GA1116
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-21
    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 number2012-000678-44
    A.3Full title of the trial
    A single-centre, randomised, four-way crossover study to investigate the measurement of the acid pocket and subsequent gastro-oesophageal reflux episodes using a novel pH/impedance catheter in subjects receiving Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid versus no treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the effect of Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid Vs no treatment on the acid pocket.
    A.3.2Name or abbreviated title of the trial where available
    Gaviscon® Double Action Acid Pocket Investigation
    A.4.1Sponsor's protocol code numberGA1116
    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 pointSenior Clinical 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 number1000
    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 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 number750
    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 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 Advance Oral Suspension
    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 Advance Oral Suspension
    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 number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM BICARBONATE
    D.3.9.1CAS number 298-14-6
    D.3.9.3Other descriptive namePOTASSIUM BICARBONATE
    D.3.9.4EV Substance CodeSUB14967MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    A single-centre, randomised, four-way crossover study to investigate the measurement of the acid pocket and subsequent gastro-oesophageal reflux episodes using a novel pH/impedance catheter in subjects receiving Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid versus no treatment.
    E.1.1.1Medical condition in easily understood language
    Study to investigate the effect of Gaviscon Double Action and Gaviscon Advance Suspension on the acid pocket and resulting reflux events.
    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 objectives of this study are to assess the formation of the acid pocket, following a high fat test meal, and associated reflux episodes in subjects receiving no treatment and when dosed with Gaviscon® Advance Liquid, Gaviscon® Double Action Liquid or Placebo Liquid.
    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)Male or female subjects aged ≥ 18 years, ≤ 50 years

    2)Subjects who have used over the counter medication to treat for heartburn, typically at least twice per month for the previous 3 months

    3)Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre

    4)Willingness to consume the refluxogenic meal

    5)Otherwise healthy subjects, in the opinion of the Investigator

    6)Those who are willing to volunteer and have provided written informed consent
    E.4Principal exclusion criteria
    Subjects to whom any of the following conditions apply must be excluded:
    1)Those with a history of gastro-oesophageal reflux disease, or reflux symptoms typically requiring self medication with over the counter or prescription medication more than twice a week on an ongoing basis.

    2)Those who have a history of active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.

    3)Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.

    4)Those who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.

    5)Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery.

    6)Those who have been hospitalised within the previous three months for major surgery or medical illness.

    7)Those who have had a clinically significant illness within the previous four weeks.

    8)Those who have taken any prescription medication or non-prescription medication (other than hormonal contraceptives) within seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.

    9)Those who have taken H2 antagonists or motility stimulants in the two weeks prior to enrolment in the study and during the study.

    10)Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study.

    11)Any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents.

    12)Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents.

    13)Those who consume abnormal quantities of coffee, tea or cola (e.g. more than six cups) according to the Principal Investigator’s judgement.

    14)Those who have taken part in any clinical study within the previous three months, or have taken part in a total of four or more studies in the last 12 months.

    15)Those who 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.

    16)Those who have evidence of columnar lined oesophagus, or any other significant abnormality in the opinion of the endoscopist and Investigator (as determined during the endoscopy procedure to place the catheter).

    17)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions. Adequate contraceptive precautions include oral or injectable contraceptives, approved hormonal implants or topical patches, intrauterine devices; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. Should the subject become sexually active while participating in the study, she and her partner must agree to use a double barrier method or condoms/diaphragms with spermicidal foam/gel/film/cream/ suppository). Subjects are to be informed verbally that a female condom and male condom should not be used together as friction between the two can result in either product failing. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or who has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).

    18)Those previously randomised into this study or those enrolled in the Validation Phase.

    19)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)
    Percentage of time that the electrode 5 cm above the SCJ is pH < 4 over a period of two hours following treatment with Gaviscon® Double Action Liquid versus Placebo Liquid.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours.
    E.5.2Secondary end point(s)
    pH change:

    1 Percentage of time that the electrode 5 cm above the SCJ is pH < 4 over a period of two hours following treatment with Gaviscon® Double Action Liquid versus the untreated state.

    2 Percentage of time that the electrode 5 cm above the SCJ, is pH < 4 over a period of four hours following treatment with Gaviscon® Double Action Liquid versus Placebo Liquid and the untreated state.

    3 Percentage of time that the electrode 5 cm above the SCJ, is pH < 4 over a period of two hours following treatment with Gaviscon® Advance versus Placebo Liquid and the untreated state.

    4 Percentage of time that the electrode 5 cm above the SCJ, is pH < 4 over a period of four hours following treatment with Gaviscon® Advance versus Placebo Liquid and the untreated state.

    5 Percentage of time at each electrode is pH < 4 at 15, 30, 45, 60, 75 and 90 minutes following ingestion of each test product at electrodes 4-11 inclusive.

    6 Mean percentage of time with pH < 4 at electrodes 1 2 and 3 during each of the four, one hour periods for Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    7 Mean percentage of time with pH < 4 at electrodes 1-3 during the four hour period for Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    8 Mean percentage of time with pH < 4 at the electrodes within the cardia (electrodes 4-7) during each of the four, one hour periods for Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    Reflux events as identified with impedance monitoring:

    9 Total number of (i) liquid, (ii) gas and (iii) mixed reflux episodes occurring in the 2- and 4-hour period following ingestion of Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    10 Total number of (i) acid and (ii) weakly acidic reflux episodes occurring in the 2- and 4-hour period following ingestion of Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    11 Number of reflux episodes reaching 15 cm above the LOS during the 2- and 4-hour period following ingestion of Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    12 Oesophageal bolus exposure to reflux (% time with liquid or mixed reflux within the oesophageal lumen) for each test product versus the untreated state during the 2- and 4-hour period following ingestion of Gaviscon® Double Action Liquid, Gaviscon® Advance Liquid versus Placebo Liquid and the untreated state.

    A post hoc correlation of the two data sets (pH and impedance) may be performed following the study. In addition, as this is a pilot study, further exploratory analysis of the data may also occur to develop other relevant secondary endpoints for future studies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 and 4 hours.
    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 No
    E.8.1.1Randomised Yes
    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 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.8.3 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 months6
    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 months6
    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: 16
    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 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 state16
    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 the ICON CPU for a Post Study Follow-up Visit 3 to 7 days after Day 3 of the last Treatment Period in each Phase.They will be asked if they have experienced any symptoms/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 testing and a urine sample will be collected for urinalysis, 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 Decision2012-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-04
    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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