Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-004308-19
    Sponsor's Protocol Code Number:ITOFD04-04
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-05-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-004308-19
    A.3Full title of the trial
    A multicentre, open-label study to evaluate the long-term safety and efficacy of itopride HCl in patients suffering from functional dyspepsia
    A.4.1Sponsor's protocol code numberITOFD04-04
    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 SponsorAXCAN PHARMA Inc.
    B.1.3.4CountryCanada
    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 Information not present in EudraCT
    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 nameItopride 100 mg (itopride HCl 110 mg) tablets
    D.3.2Product code HSR-803
    D.3.4Pharmaceutical form 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 122892-31-3
    D.3.9.2Current sponsor codeHSR-803(Laboratory use)
    D.3.9.3Other descriptive nameN-{p-[2-(Dimethylamino)ethoxy]benzyl}veratramide hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of abdominal symptoms in patients with functional dyspepsia
    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
    To evaluate the safety profile of itopride 100 mg (itopride HCl 110 mg) tid when given long-term, testing the following variables every 8 weeks for a period of up to 52 weeks:

    - Laboratory testing
    - Adverse Events
    - Compliance

    Cardiac function (12-lead ECG) will be tested at baseline, week 24 and 52.
    E.2.2Secondary objectives of the trial
    To evaluate the therapeutic benefit over long-term by measuring:

    - Global patient assessment of efficacy utilizing the response to a single question: “Please rate the strength of your upper abdominal complaints in the past 14 days. Compared to the condition at the outset of treatment, how much have they changed? Please mark the statement that best applies to you: symptom-free, markedly improved, slightly improved, unchanged, worse”.

    This efficacy variable will be measured every 8 weeks for a period of up to 52 weeks.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    For patients having completed ITOFD04-03 (double-blind study) (EudraCT number: 2004-000448-26) the inclusion criteria are as follows:

    -Patients must have completed the 8 week double-blind period;
    -Female patients must not be pregnant (must have a negative serum pregnancy test);
    -Patients must sign an Informed Consent Form, which must comply with EMEA regulations, US, Canadian or ICH guidelines and local requirements.

    For patients not having been randomized to the double-blind study (ITOFD04-03) the inclusion criteria are as follows:

    -Male and female outpatients;
    -18-65 years old;
    -Meet the following Rome II criteria: (1) Presence of persistent or recurrent dyspepsia (pain or discomfort centered in the upper abdomen). Discomfort may be characterized by or associated with upper abdominal fullness, early satiety, bloating, or nausea. (2) No evidence of organic disease that is likely to explain the symptoms;
    -Known H. pylori status (can be positive or negative), as confirmed by C-13 within 7 days prior to enrolment;
    -Signed informed consent at screening visit.
    E.4Principal exclusion criteria
    For patients having completed ITOFD04-03 (double-blind study) the exclusion criteria are as follows:
    -Patients with extrapyramidal symptoms;
    -Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry. See below for a list of this exclusion criteria.

    For patients not having been randomized to the double-blind study (ITOFD04-03) the exclusion criteria are as follows:

    -No organic disease, such as esophagitis, gastric or duodenal ulcer, esophageal or gastric neoplasia, as confirmed by either an upper endoscopy during the past 6 months, or with a barium meal, conducted at the time of the screening visit;
    -Patients suffering mainly or exclusively from symptoms corresponding to reflux disease;
    -Clinical evidence or diagnosis of gallbladder or biliary tract disease, pancreatic disease confirmed by upper abdominal ultrasound;
    -Clinical evidence or diagnosis of chronic inflammatory bowel disease;
    -Patients with clinically relevant ECG abnormalities such as a QRS duration > 110 msec, heart rate < 50 beats per minute or a QTc duration of > 470 msec on the screening ECG;
    -Patients with known arrhythmias, such as: chronic/paroxysmal atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or “torsades de pointe”.
    -Active psychiatric disorder that would interfere with the study objectives;
    -Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient.
    -Severe hepatic, renal, cardiac, metabolic, hematological or malignant diseases (including prolactin dependent tumors) or clinically relevant deviations in laboratory values (AST/ALT) greater than twice the upper limit of normal, serum creatinine > 2 mg/dL, hyperthyroid or hypothyroid patient according to the medical judgment of the investigator. Patients with hypokalemia (serum potassium < or = 3.5 mmol/L) and hypomagnesemia (serum magnesium < 1.7 mg/dL);
    -History of any known hypersensitivity to the ingredients of the investigational drug;
    -Patients with a genetic disease called trimethylaminuria (fish odor syndrome).
    -Patients with laxative abuse, as judged by the investigator;
    -Patients with any known specific food intolerance (whose symptoms disappear completely and persistently if he/she does not eat the particular food, e.g., lactose intolerance);
    -Pregnancy or lactation;
    -Women with childbearing potential who do not use a medically accepted method of contraception (e.g., hysterectomy, sterilization, oral contraception);
    -Known alcoholism or drug abuse;
    -Participation in a clinical trial (other than ITOFD04-03) within one month prior to enrolment or during the course of the study;
    -Celiac disease or enteropathy;
    -Patients with extrapyramidal symptoms.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:

    -General safety profile of itopride HCl as measured by adverse events reporting and performance of safety lab tests every 8 weeks;
    -Cardiac safety measured by repeated 12 lead ECGs, at month 0, 6 and 12;
    -Physical exam and vital parameters at month 0, 6 and 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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    For this protocol, the 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 years2
    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 years2
    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 Information not present in EudraCT
    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 2005-05-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 300
    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)
    At the end of the study, patients will be advised by their treating physician of the possible treatment options. Treatment will not be different from expected normal treatment of that condition.
    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 Decision2005-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-09-22
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 22:37:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA