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    Summary
    EudraCT Number:2005-005621-55
    Sponsor's Protocol Code Number:99010206E
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-005621-55
    A.3Full title of the trial
    Z-338: A Phase IIb, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety in Subjects with Functional Dyspepsia
    A.4.1Sponsor's protocol code number99010206E
    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 SponsorZeria Pharmaceutical Co., Ltd.
    B.1.3.4CountryJapan
    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 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 nameZ-338
    D.3.2Product code Z-338
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 773092-05-0
    D.3.9.2Current sponsor codeZ-338API
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 placeboFilm-coated tablet
    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
    Functional Dyspepsia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10064536
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of two doses of Z-338 in subjects with
    functional dyspepsia (FD) in order to determine the optimal dosage for Phase III
    clinical trials
    E.2.2Secondary objectives of the trial
    ·To evaluate and identify appropriate primary and secondary efficacy parameters for use in Phase III clinical trials
    ·To evaluate and identify appropriate inclusion and exclusion criteria for use in Phase III clinical trials
    ·To assess the safety profile of Z-338 in patients with FD
    ·To assess relapse rate on weekly basis during 4weeks follow-up period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects presenting diagnosis of FD as defined by the Rome II Criteria (Gut 1999; 45 [Suppl. 2]: II 37-II 42) - “At least 12 weeks, which need not be consecutive, within the preceding 12 months of: (1) Persistent or recurrent dyspepsia; and (2) No evidence of organic disease (including at upper endoscopy) that is likely to explain the symptoms; and (3) No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (i.e. not irritable bowel).” (Visit 0 or 1).
    2. Subjects must have consulted for FD problems at least once during the last 12 months prior to study entry (Visit 0 or 1).
    3. It should be confirmed that Postprandial fullness or Early satiety should be the most bothersome symptom (primary complaint) during the last 14 days prior to the eligibility period (Visit 1) by review of the Screening Questionnaire.
    4. Severity of Postprandial fullness, Early satiety, Upper abdominal bloating, Nausea, and Epigastric pain should be at least moderate for at least 2 symptoms including the most bothersome and for 2 days or more per week during the past 14 days prior to the eligibility period (Visit 1) by review of the Screening Questionnaire.
    5. Subjects must provide witnessed written informed consent prior to any study procedures being performed (Visit 0 or 1).
    6. Subjects must be aged between 18 and 70 years inclusive on the day the Informed Consent is signed (Visit 0 or 1).
    7. Male or female subjects. Female subjects of childbearing potential must provide a negative pregnancy test (urine dipstick) at Visit 2, unless surgically sterilised, and must also be using acceptable birth control methods (e.g. contraceptive implant, injectable or patch hormone therapy, oral contraceptives in combination with barrier methods [e.g. condoms], intrauterine device, sexual abstinence, or surgical sterilisation of the subject or the subject’s sexual partner).
    8. Subjects must be able to understand the study, comply with the study requirements and return to the investigational site for assessments at specified times.
    9. Subjects with a normal upper endoscopy (no ulcers or erosions) within 6 months prior to study entry (Visit 0 or 1) or between Visit 0 and 7 days after Visit 1 (in case a subject has not had an upper endoscopy within 6 months).
    E.4Principal exclusion criteria
    1. Subjects who have received treatment with an investigational drug within 28 days prior to study entry (Visit 0 or 1).
    2. Subjects with any condition which, in the opinion of the investigator, makes the subject unsuitable for entry into the study (Visit 0 or 1).
    3. Females who are pregnant or lactating (Visit 0 or 1).
    4. Subjects who have taken proton pump inhibitors (PPIs) within 28 days prior to the eligibility period (Visit 1). Subjects taking PPIs will be asked to discontinue medication and return in 4 weeks for Visit 1 (Visit 0). However, subjects who have taken PPIs for equal to or less than 3 days during the period from 28 days to 15 days prior to the eligibility period (Visit 1) may be included in the study.
    5. Subjects who have taken drugs that affect gut motility, perception and/or acid secretion: H2 antagonists, antacids, cisapride, domperidone, metoclopramide and any other kind of drug, including psychotropic or antidepressant agents for treatment, that modify meal accommodation, sensitivity to distension, and/or gastric emptying within 14 days prior to the eligibility period (see list of prohibited medications, Appendix X). Subjects taking medications for dyspepsia related symptoms will be asked to discontinue medication and return in 2 weeks for Visit 1 (Visit 0). However, subjects who have taken these medications for equal to or less than 3 days during the last 14 days prior to the eligibility period (Visit 1) may be included in the study. Subjects may take one low dose antidepressant but must be stabilised for at least 6 months (see Section 10.6).
    6. Subjects with active uncontrolled psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression (except at least 6 months stable condition by using one form of medication of standard dose antidepressant, see Section 10.6), alcohol or substance abuse in the last 2 years.The antidepressants Amitriptylin and Nortriptylin are always forbidden even if prescribed alone. Subjects taking one and the same medication of anxiolytics, sedatives or hypnotics only once a day for sleep problems are not excluded (Visit 0 or 1).
    7. Subjects with known hypersensitivity to gastroprokinetic drugs/agents (Visit 0 or 1).
    8. Subjects taking non-steroidal anti-inflammatory drugs (NSAIDs), with the exception of subjects taking prophylactic doses of aspirin for cardiovascular disease (not exceeding 500 mg per day, See Section 10.6); Visit 0 or 1.
    9. Subjects with confirmed organic gastrointestinal disease (Visit 0 or 1).
    10. Subjects with former digestive surgery possibly affecting gastrointestinal motility including endoscopic procedure for gastroesophageal reflux disease [GERD] and obesity. However, subjects with former appendectomy and/or laparoscopic surgery may be included in the study (Visit 0 or 1).
    11. Subjects with a significant renal (serum creatinine >2 x upper limit of normal [ULN]), hepatic (alanine transaminase [ALT], aspartate transaminase [AST], gamma glutamyltransferase [GGT], bilirubin >2 x ULN), cardiovascular, pulmonary, endocrine, metabolic or haematological condition (Visit 1).
    12. Subjects with any evidence of, or treatment for, malignancy (with the exception of basal cell carcinoma) within the last 5 years (Visit 0 or 1).
    13. Subjects presenting with primary complaints relieved by stool movements (irritable bowel syndrome [IBS]); Visit 0 or 1.
    14. Subjects who have received Helicobacter pylori (H. pylori) eradication therapy in the 3 months prior to study entry (Visit 0 or 1).
    15. Subjects with diabetes (cut off of fasting glucose 120 mg/dL) (Visit 1).
    16. Subjects with cardiovascular problems, history of arrhythmias, clinically significant electrocardiogram (ECGs) abnormalities and\or subjects with any kind of risk of QT-time prolongation. However, subjects who suffer from controlled and non complicated hypertension may be included (Visit 1).
    17. Subjects taking QT-time prolonging drugs such as macrolide antibiotics as well as CYP3A4 inhibiting azole-type antimycotics (see list of prohibited medications, Appendix X); Visit 0 or 1.
    18. Subjects with body mass index (BMI) over 30 (Visit 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of responders to the Global Subject Outcome Assessment at Visit 5 (Week 12).
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-09. Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 282
    F.4.2.2In the whole clinical trial 282
    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 Decision2006-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-05
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