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    EudraCT Number:2012-002183-27
    Sponsor's Protocol Code Number:T-019
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-02-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-002183-27
    A.3Full title of the trial
    Can netazepide eradicate the inflammatory response of the gastric mucosa to H. pylori infection?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gastroscopy study of netazepide and H. pylori infection
    A.3.2Name or abbreviated title of the trial where available
    Gastroscopy study of netazepide and H. pylori infection; version 1
    A.4.1Sponsor's protocol code numberT-019
    A.5.4Other Identifiers
    Name:HMR codeNumber:12-502
    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 SponsorHammersmith Medicines Research
    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 supportTRIO Medicines 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 No
    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 nameNetazepide
    D.3.2Product code YF476
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnetazepide
    D.3.9.1CAS number 155488-25-8
    D.3.9.2Current sponsor codeYF476
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboCapsule, hard
    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
    Gastritis associated with H. pylori infection
    E.1.1.1Medical condition in easily understood language
    Inflammation of the stomach lining caused by infection with H. pylori bacteria.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10051790
    E.1.2Term Helicobacter pylori gastritis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out if netazepide can heal inflammation of the stomach lining caused by H. pylori infection.

    E.2.2Secondary objectives of the trial
    To find out if netazepide: has any effect on 'biomarkers' - substances related to stomach health stomach health and function (gastrin, chromogranin A and pepsinogens I & II); can get rid of H. pylori infection; can get rid of symptoms of indigestion; and has any important side effects in people with H. pylori infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women aged 30-75 years
    2. Positive H. pylori blood test and breath test
    3. Otherwise good general health as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
    4. Body mass index 18-32 kg/m^2
    5. Able to give fully-informed, written consent
    6. Able to communicate with study personnel
    7. Reliable, willing, and likely to comply with the protocol
    8. Consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS)
    E.4Principal exclusion criteria
    We exclude the participants who meet the following criteria:

    * not in good general health (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine); abuse of alcohol or drugs; drink, on average, more than 21 units of alcohol weekly (14 units for women); taken certain medicines or herbal remedies (ones that may affect the way the body handles or responds to the study medicine) up to 12 weeks before screening; have had a serious reaction to any medicine - particularly benzodiazepines; have had any condition or operation that might affect the way the body absorbs medicines; have had previous treatment for an H. pylori infection; objection by GP on medical grounds because they might increase the risk; or confound the assessment of netazepide; mental illness might compromise consent;

    * pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol - because of the potential risk to the unborn or breastfed baby;

    * have donated blood, or taken part in another study, within the past 3 months; or don't agree not to donate blood, or take part in another study, during the 3 months after this study - because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood; or

    * smokers of more than 5 cigarettes a day - because participants must be able to comfortably abstain from smoking during the study

    Those criteria are designed to select healthy participants, who are robust enough to recover quickly from any adverse effects of netazepide.
    E.5 End points
    E.5.1Primary end point(s)
    * Visual assessment of gastric mucosa at gastroscopy
    * Histology and real-time PCR of gastric biopsies for biomarkers (such as chromogranin A (CgA), histidine decarboxylase (HDC), matrix metalloproteinase-7 (MMP-7) and interferon gamma)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Gastroscopy with biopsies: at baseline (Visit 3, before 1st dose) and after 12 weeks' treatment (Visit 7) with the study medicine
    E.5.2Secondary end point(s)
    1. 13C urease breath test and Giemsa staining of gastric biopsies for the presence of H. pylori infection

    2. Serum gastrin and pepsinogens I & II, and plasma CgA concentrations

    3. Trough and peak pharmacokinetic (PK) parameters of netazepide

    4. Symptoms of dyspepsia (indigestion)

    5. Safety and tolerability of netazepide as judged by medical examination; ECG; vital signs; safety tests of blood and urine; and adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Breath test: at screening (Visit 2) and after 12 weeks' treatment (Visit 7)

    Biopsies: taken at gastroscopy before and after 12 weeks' treatment

    2. Samples for gastrin, pepsinogens 1 and 2, and CgA, at baseline, after 3, 6, 9 and 12 weeks' treatment, and at follow-up.

    3. Samples for PK of netazepide: predose and 1 hour post-dose (tmax) after the first dose, and after 6 and 12 weeks' treatment.

    4. Dyspepsia questionnaire before and after 12 weeks' treatment.

    5. Medical examination, ECG and vital signs: at baseline and after 3, 6, 9 and 12 weeks' treatment.

    Safety blood and urine tests: at baseline and after 3, 6, 9 and 12 weeks' treatment.

    Adverse events: monitored continually throughout the study.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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. 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 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 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.8.5.1Number of sites anticipated in the EEA1
    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
    In accordance with the Human Tissue Act, no biopsy sample can be stored or analysed after the study has been declared over. Therefore, the end of the trial is defined as the last visit of the last subject, or completion of the last bioanalysis, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Participants can’t carry on taking the study medicine after the study has finished, even if they get some unexpected benefit from it. We inform participants of that before they consent to take part.

    If participants still have the H. pylori infection at the end of the study, we'll offer them one course of recommended treatment to clear the infection.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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