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    The EU Clinical Trials Register currently displays   38487   clinical trials with a EudraCT protocol, of which   6324   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-021630-63
    Sponsor's Protocol Code Number:GA1001
    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:2011-01-31
    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 number2010-021630-63
    A.3Full title of the trial
    A randomised, double blind placebo controlled study in patients with reflux symptoms to assess suppression of gastro-oesophageal reflux by ‘Gaviscon Double Action Peppermint liquid’ using the BRAVO system
    A.3.2Name or abbreviated title of the trial where available
    Gaviscon Double Action vs placebo study
    A.4.1Sponsor's protocol code numberGA1001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN52169198
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorReckitt Benckiser
    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 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 Double Action
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benkiser
    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 Peppermint Flavour
    D.3.2Product code Gaviscon Double Action Liquid Peppermint Flavour
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    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.3.10 Strength
    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.3.10 Strength
    D.3.10.3Concentration number325
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Gastro-oesophageal reflux disease (GORD)
    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
    This project will provide extensive mechanistic (i.e. effect of product on underlying pathophysiological mechanism of disease / suppression of acid reflux events) and pilot clinical data (i.e. effect of product on patient symptoms) for the use of Gaviscon Double Action Peppermint liquid in patients presenting with predominantly typical reflux symptoms (heartburn, acid regurgitation) to a single, referral centre for oesophageal measurement serving a multi-ethnic community of 6 million in South-East England.

    The primary objective of this study is to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid reflux events in patients with typical reflux symptoms.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid and weakly acid reflux events, oesophageal acid exposure, pepsin in expectorated saliva and clinical benefit in terms of patient reports of reflux symptoms in patients with typical reflux symptoms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: ≥ 18 years ≤ 70 years
    2. Sex: male and female patients were eligible for entry.
    3. Primary diagnosis: those with self-rated at least moderate heartburn or acid regurgitation within 60 minutes following ingestion of a refluxogenic meal on at least 3 occasions a week at the screening visit.
    4. Agreement to withhold acid suppressant PPI and H2receptor blocking medications and other medications that affect gastro-intestinal function for 6 days and 3 days respectively prior to the test and during 4 days of monitoring.
    5. Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the test and during 4 days of monitoring.
    6. Patients who gave written informed consent
    E.4Principal exclusion criteria
    1. Those with prominent gastrointestinal symptoms or disease other than reflux (including atypical symptoms e.g. cough, sore throat, belching, nausea)
    2. Those with difficulty swallowing (dysphagia), gastrointestinal bleeding, weight loss (>5% body weight) or other alarm symptoms suggestive of neoplastic or severe inflammatory disease within the last 12 months
    3. Those with a history or symptoms suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett’s oesophagus or systemic sclerosis.
    4. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection
    5. Those with known hypophosphataemia or phenylketonuria.
    6. Those with severe constipation or history of colonic stenosis.
    7. Those with major oesophageal dysmotility on manometry, e.g. achalasia
    8. Those with severe reflux oesophagitis on endoscopy (LA grade III-IV) or Barrett Oesophagus on endoscopy.
    9. Those with significant co-morbidity requiring ongoing treatment or investigation
    10. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants
    11. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility)
    12. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. sexual 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]. A woman of childbearing potential is defined as any female who has not undergone the menopause or has not had an hysterectomy or surgical sterilisation procedure, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
    13. Those that do not withhold acid suppressant PPI and H2 receptor blocking medications for 6 days and 3 days respectively prior to the test and during 4 days of monitoring.
    14. Those that do not withhold antacid or alginate medications for 1 days prior to the test and during 4 days of monitoring (5 days in total)
    15. Those who have any previous history of allergy or known intolerance to any of the study drugs or following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate, calcium carbonate, carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, peppermint flavour, sodium hydroxide, Placebo: hydrogenated glucose syrup, peppermint flavour, potassium sorbate, methyl paraben, xanthan gum r80, propyl paraben, citric acid.
    16. Failure to accept or to comply with standard requirements for activity and diet during pH testing as set out in appendix II
    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 outcome of this study is to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid reflux events in patients with typical reflux symptoms. The primary measure is the number of acid reflux events during 48hr Gaviscon Double Action or matched placebo study period compared to the 48hr “no treatment” study 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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    Last subject undergoing trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    As patients are referred for standard reflux assessment a routine pH study will need to be performed regardless of inclusion into the study. Therefore the outcome will have potential long term effects as the decision for medical or surgical therapy will be made by the referrer based in part on these results
    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 Decision2011-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-11-08
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