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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-004470-25
    Sponsor's Protocol Code Number:GA1214
    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:2012-11-12
    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 number2012-004470-25
    A.3Full title of the trial
    A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon® Double Action Mint 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
    Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI treatment
    A.3.2Name or abbreviated title of the trial where available
    Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI's
    A.4.1Sponsor's protocol code numberGA1214
    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 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 Mint
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser
    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 Mint
    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.3.9.1CAS 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 ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS 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 ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number426
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS 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 ml millilitre(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.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
    Patients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatment
    E.1.1.1Medical condition in easily understood language
    Gastro Oesophageal Reflux Disease (GORD) patients with inadequate response to PPI treatment
    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 pilot study is to assess the efficacy of Gaviscon® Double Action Mint 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 of this pilot study are to assess the efficacy of Gaviscon® Double Action Mint compared with Matched Placebo Liquid in change in duration, frequency 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 the efficacy of Gaviscon® Double Action Mint compared with Matched Placebo Liquid in subject satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent has been obtained.
    2. Age: ≥ 18 years.
    3. Sex: male or female.
    4. Current evidence of symptomatic GORD in accord with the Montreal definition following treatment with a proton pump inhibitor. This evidence can be based solely on symptom characteristics.
    5. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least three days a week during the two 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;
    • Mild: awareness of symptom but easily tolerated
    • Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
    • Severe: incapacitating symptom with inability to perform normal activities, including sleep
    6. Treatment with once daily PPI for at least the previous 4 weeks at standard doses, eg, lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day.
    7. Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the investigator.
    8. Status: subjects will be members of the public who respond to an advertisement or letter from the site.

    Following the 7-day run in period, patients will be assessed against the following inclusion criteria before randomisation.
    1. Completion of the run-in diary card and questionnaires on each of the seven days of the run-in period.
    2. At least one reflux symptom (heartburn or regurgitation) of at least mild or moderate intensity measured during the 7-day run-in period (from the HRDQ questionnaire) and a summarised 7-day score of at least 18 (e.g. corresponding to 3 days with moderate heartburn on three occasions per day). (The daily score will be calculated as intensity x frequency, where intensity is scored as 0 = none, 1 = mild, 2 = moderate and 3 = severe and frequency is scored as 0 = none, 1 = once, 2 = twice, 3 = thrice, 4 = 4 or 5 times, 5 = 6 – 10 times and 6 = more than 10 times or constant).
    3. Compliance with PPI treatment (once daily in the morning) on all seven days of the run-in period.
    E.4Principal exclusion criteria
    1. Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, hiatus hernia (diagnostically confirmed), recent (with last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
    2. A recent history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g or 17.5 units).
    3. Recent cardiac chest pain.
    4. Recent, significant unexplained weight loss of greater than 6 kg in the last 6 months.
    5. Gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months.
    6. Non-steroidal anti-inflammatory drugs or other analgesics in doses that might compromise symptom recording.
    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):
    H2-receptor antagonists
    Mucous membrane protection drugs
    Anti-cholinesterase drugs, sucralfate or misoprostol preparations
    Antacids (including Gaviscon)
    8. Current enrolment in another study or involvement in a previous symptom relief Gaviscon study in the past year.
    9. Previous surgery of the oesophagus, stomach or duodenum.
    10. Potential language problems in understanding information and recording symptoms.
    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 subjects 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 10.44).
    13. Pregnancy or lactating mother.
    14. Subjects with known hypophosphataemia, phenylketonuria or hypercalcaemia
    15. Subjects with severe/impaired renal function or insufficiency
    16. 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.
    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 the change in HRDQ scores [heartburn and regurgitation only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2 and Visit 3
    E.5.2Secondary end point(s)
    The following will be compared between treatments:
    • Change in HRDQ scores [dyspepsia only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • Change in number of days with night-time symptoms (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • Change in whether the patient has any night-time symptoms (over the 7 days of treatment) from baseline (over the 7 days of run-in).
    • Change in duration of symptoms [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • Change in frequency of individual symptoms (heartburn, regurgitation, dyspepsia [taken from HRDQ]) (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • Change in ReQuest™ GI Scores [short version only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
    • Change from baseline in patient satisfaction scores at the end of the study.
    • The number of symptom-free days (using both HRDQ and ReQuest™ individually) following one week of treatment with study medication, beginning on day 1.
    • Change in number of symptom-free days (using both HRDQ and ReQuest™ individually) (mean over 7 days of treatment) from baseline (mean over 7 days of run-in).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2 and Visit 3
    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 concerned4
    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 years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    No other additional care of study subjects will take place following the end of the study. The treatment of the subject’s condition will follow normal clinical practice.
    AEs starting after the end of the study will not be followed up. All suspected adverse reactions reported post-study will be processed in accordance with RB's pharmacovigilance procedures.
    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 Decision2012-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-23
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