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    Summary
    EudraCT Number:2004-000448-26
    Sponsor's Protocol Code Number:ITOFD04-03
    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:2005-06-06
    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 number2004-000448-26
    A.3Full title of the trial
    A multicentre, randomized, double-blind, placebo-controlled study of the efficacy and safety of Itopride HCl in patients suffering from functional dyspepsia
    A.4.1Sponsor's protocol code numberITOFD04-03
    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. (Axcan Pharma International BV is subsidiary of Axcan 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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameITAX
    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.3.8INN - Proposed INNitopride hydrochloride (of the free base)
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    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 establish the efficacy of itopride HCl 100 mg t.i.d compared with placebo in improving the symptoms of functional dyspepsia after 8 weeks of treatment. Efficacy will be measured using an adapted version of the LDQ (Leeds Dyspepsia Questionnaire), which will monitor the change in the overall severity of functional dyspepesia during the treatment phase. The LDQ questions assessing the symptoms of upper abdominal pain and fullness will be used as the primary outcome measure, along with the 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”.
    E.2.2Secondary objectives of the trial
    To compare itopride HCl and placebo for the following secondary efficacy variables:
    -Change from baseline in the overall severity of FD as measured at week 4 and 8, using the LDQ severity score.

    -Change from baseline in the patient's quality of life as measured by the Nepean Dyspepsia Index (NDI) at week 0, 2, 4 and 8.

    -Change from baseline in the overall severity of FD as measured by the NDI symptom score at week 0, 2, 4, and 8.

    -Change in the Global Patient Assessment of the efficacy of study medication versus placebo measured at week 2 and 4.

    Safety Endpoints:·

    -To establish the safety profile of itopride HCl as measured by adverse events reporting, vital parameters and performance of safety lab tests.

    -To establish cardiac safety measured by repeated 12 lead ECGs, at screening, baseline, 2- and 8-week visits.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Male and female outpatients (18-65 Years).

    -Patients need to meet the following Rome II criteria: (1)Presence of persistent or recurrent dyspepsia (pain or discomfort centered in the upper abdomen). Discomfort may be characterised 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. (3) No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (not IBS).

    -All patients enrolled must have a negative upper GI endoscopies to exclude organic disease, such as esophagitis, gastric or duodenal ulcer, esophageal or gastric neoplasia, within 1 month prior to enrolment. At the time of the endoscopy, patients must have been off Proton Pump Inhibitors (PPIs) and H2-receptor antagonists for at least 14 days.

    -Patients in whom heartburn is infrequent, not exceeding a frequency of one episode per week, and is subordinate to their abdominal pain or discomfort.

    -Evidence of H. pylori negative status, as confirmed by either C-13 within 7 days prior to enrolment.

    -Baseline severity of at least moderate on the LDQ (total score of 9 and above).
    E.4Principal exclusion criteria
    -Patients suffering mainly or exclusively from symptoms corresponding to reflux disease.

    -Patients suffering from regurgitation and/or vomiting.

    -Abnormal upper GI endoscopy findings

    -Clinical evidence or diagnosis of gallbladder or biliary tract disease, pancreatic disease confirmed by upper abdominal ultrasound 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.

    -Health conditions that would interfere with the study objectives or might impair the compliance of the patient.

    -Severe hepatic, renal, cardiac, metabolic, hematological or malignant diseases 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 judgement of the investigator.

    -Patients with hypokalemia (serum potassium less than or equal to 4 mmol/l) and hypomagnesemia (serum magnesium < 1.7 mg/dl).

    -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).

    -Smoker who has significantly changed his/her smoking habits within 14 days prior to administration of study medication, or non-smoker who has become a smoker within 14 days prior to administration of study medication.

    -Pregnancy or lactation.

    -Women with childbearing potential who do not apply a medically accepted method of contraception.

    -Known alcoholism or drug abuse.

    Participation in another clinical trial within one month prior to enrolment or during the course of the study.

    -Celiac disease or enteropathy.
    E.5 End points
    E.5.1Primary end point(s)
    The two co-primary efficacy endpoints will be:

    -Questions 1 and 8 from the LDQ, measuring pain in the upper abdomen and feeling of fullness, respectively.

    -The Global Patient Assessment of efficacy.

    Both variables will be evaluated in terms of responder/non-responder at the end of week 8 within the Intent to Treat (ITT) population. In order to be classified as a responder, patients will need to be either symptom-free or markedly improved according to the Global Patient Assessment of Efficacy, and will need to have shown improvement with respect to the LDQ grading for at least one of the symptoms (upper abdominal pain or fullness), but no deterioration of the other one.
    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) 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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 No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 500
    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 Decision2004-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-12-15
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