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    Summary
    EudraCT Number:2007-005008-41
    Sponsor's Protocol Code Number:2007033
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-19
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-005008-41
    A.3Full title of the trial
    A Phase II, Randomized, Adaptive Design, Multicenter, Parallel Group, Placebo-controlled, 58-day, Dose-ranging Study of ATI-7505 in Patients with Postprandial Distress Syndrome
    A.4.1Sponsor's protocol code number2007033
    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 SponsorProcter & Gamble Pharmaceuticals
    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 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 nameATI-7505
    D.3.4Pharmaceutical form 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 INNnot assigned yet
    D.3.9.1CAS number 860174-12-5
    D.3.9.2Current sponsor codeATI-7505 dihydrochloride
    D.3.9.3Other descriptive nameATI-7505
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeactive substance is synthetic origin
    D.IMP: 2
    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 nameATI-7505
    D.3.4Pharmaceutical form 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 INNnot assigned yet
    D.3.9.1CAS number 860174-12-5
    D.3.9.2Current sponsor codeATI-7505 dihydrochloride
    D.3.9.3Other descriptive nameATI-7505
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typeactive substance is synthetic origin
    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 placeboTablet
    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
    Postprandial Distress Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064536
    E.1.2Term Functional dyspepsia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of 3 oral dosing regimens of ATI-7505 compared to placebo in
    patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of PDS symptoms on at least 50% of the treatment days.
    E.2.2Secondary objectives of the trial
    - To determine the safety and tolerability of ATI-7505 in patients with PDS;
    - To determine the time to recurrence of the 2 primary PDS symptoms measured during the 42-day primary efficacy period; and
    - To determine the effect of ATI-7505 treatment on health-related quality of life (QOL) indices in patients with PDS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At screening:

    Patients are eligible to participate in the study if they:

    a. are willing and able to provide written informed consent;
    b. are male or female between 18 and 75 years of age, inclusive, at Screening;
    c. were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening;
    d. have experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening along with one or more of the following symptoms for PDS:
    • early satiety,
    • bothersome postprandial fullness,
    • upper abdominal bloating or distention,
    • postprandial nausea,
    • excessive belching;
    e. had a normal upper GI endoscopy within the past year (ie, no evidence of erosions or other mucosal abnormalities).
    g. if female, are:
    • postmenopausal (at least 1 year without spontaneous menses), or
    • surgically sterile (tubal ligation or hysterectomy), or
    • using highly effective (ICH 1997) contraception (eg, oral, intramuscular, transdermal, or implanted hormonal contraception [at least 3 months prior to enrollment], sexual partner with non-reversed vasectomy [with azoospermia in 2 tests], 2 independent barrier methods [ie, a combination of 2 of the following methods: condom, diaphragm, or properly applied spermicide], or intra-uterine device). Women who are using contraception will be required to have a pregnancy test (urine) at the Screening, Baseline, Day 29, and Day 58 visits;
    h. have had no significant changes in diet in the 2 months prior to screening and are not planning such changes for the duration of the study;
    i. if taking proton pump inhibitors (PPIs), oral contraceptives, and/or selective serotonin reuptake inhibitors (SSRIs), have been on a stable dose for at least 3 months.

    At randomization:

    Patients are eligible for randomization to a treatment group in the study if they:

    a. have no more than 2 PDS symptom-free days per week during the 2-week run-in period;
    b. have an average PDS-symptom score for either primary symptom (early satiety or
    bothersome postprandial fullness) of greater than mild severity (>2 on the 1-5 Likert scale) for the 2-week run-in period;
    c. have no more than 1 day per week with an EPS-symptom score of greater than moderate severity (>3 on the 1-5 Likert scale) during the 2-week run-in period;
    d. have an average EPS score of, at most, mild severity (≤2 on the 1-5 Likert scale) for each week of the 2-week run-in period;
    e. have no more than 3 days per week with heartburn during the 2-week run-in period;
    f. have been at least 70% compliant during the 2-week run-in period with electronic patient reported outcome (ePRO) e-diary entries (at least 10 out of 14 e-diary entries); and
    g. have not missed more than 3 consecutive days of e-diary entries.
    E.4Principal exclusion criteria
    Patients will be excluded from admission to the 2-week run-in period or randomization to a treatment group if they have/are:

    a. a body mass index (BMI) >32;
    b. current peptic ulcer disease (PUD);
    c. heartburn that occurs >3 times per week;
    d. current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening;
    e. a total Patient Health Questionnaire 15-item Somatic Symptom Severity Scale (PHQ-15) score >17
    f. presence or suspected presence of unstable coronary artery disease, organic gastrointestinal disease, or collagen vascular disease within the 6 months prior to screening;
    g. any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening;
    h. taking prohibited medications specified in Section 3.3 within 30 days prior to screening or planning to take prohibited medications at any time during the study;
    i. at screening, a QT interval corrected for heart rate using Bazett’s correction formula (QTcB) >440 msec as determined by the Investigator. The ECG core laboratory will also determine the QTcB and the QT interval corrected for heart rate using Fridericia’s correction formula (QTcF). If either QTcB or QTcF reported by the ECG core laboratory exceeds 440 msec, the patient will not be randomized;
    j. at the Baseline visit, a QTcB >440 msec as determined by the Investigator;
    k. a clinically significant abnormal 12-lead ECG (eg, with evidence of acute or recent
    myocardial infarction or ischemia, rhythm disturbance, or conduction abnormality other than first degree AV block);
    l. a family history of sudden death at age <40 years;
    m. a personal or family history of long QT syndrome;
    n. evidence of current or recent alcohol or drug abuse within the 6 months prior to screening;
    o. participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
    p. a serum potassium, magnesium, or calcium value outside the laboratory reference range at screening or baseline;
    q. a serum aspartate transaminase (AST), alanine transaminase (ALT), or gamma glutamyl transferase (GGT) ≥3 times the upper limit of the normal laboratory reference range at screening or baseline, or a bilirubin value ≥2 times the upper limit of the normal laboratory reference range at screening;
    r. diabetes mellitus requiring insulin therapy or oral hypoglycemic agents;
    s. a hemoglobin A1c (Hgb A1c) >7% at screening;
    t. any laboratory value outside the laboratory reference range at screening or baseline that are considered to be clinically significant by the Investigator;
    u. a positive pregnancy test or are nursing or planning a pregnancy during screening, run-in, active treatment, or the follow-up period; or
    v. a history or presence, upon clinical evaluation, of any illness or condition that might impact the safety of study drug administration or evaluability of drug effect based on the Investigator’s discretion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the responder rate for each treatment group through Day 42. Responder rate is defined as the percentage of patients who have adequate symptom relief at least 50% (≥50%) of the treatment days during the 42-day primary efficacy period based on daily patient responses via telephone electronic diary (eDiary) to the question, “In the past 24 hours, have you had adequate relief of either or both of these 2 meal-related symptoms: uncomfortable fullness after a meal or the inability to finish a meal?”

    In this study an adaptive interim efficacy analysis (Bauer and Kohne 1994, Posch et al 2005) will be utilized when 25% and 50% of the planned patients have completed at least 6 weeks of study drug treatment. These analyses will be conducted by an external independent statistician. One of the 4 possible courses of action
    resulting from the interim analyses is changing the primary efficacy endpoint to the mean score change from baseline over time for the 2 primary PDS symptoms (fullness and early satiety) measured during the 42-day primary efficacy period. If, after an interim analysis, the primary endpoint is changed to the mean change from baseline evaluation, then only patients randomized after the change in the primary endpoint who took at least 1 dose of the study medication will be included in the new primary analysis.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Adaptive Design
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 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
    The study is considered terminated upon completion of all patient treatments and evaluations.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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) 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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 900
    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)
    There are no plans for treatment or care beyond standard medical treatments of the respective 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 Decision2008-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
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