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    Summary
    EudraCT Number:2004-002762-38
    Sponsor's Protocol Code Number:Clin-AGI001-001
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-07
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2004-002762-38
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study of AGI 001 in the treatment of functional dyspepsia
    A.4.1Sponsor's protocol code numberClin-AGI001-001
    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 SponsorAGI Therapeutics Limited
    B.1.3.4CountryIreland
    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 nameAGI 001
    D.3.2Product code AGI 001
    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 INNPindolol (S -isomer)
    D.3.9.1CAS number CAS 26328 -1
    D.3.9.2Current sponsor codeAGI 001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Yes
    D.3.11.13.1Other medicinal product typePindolol is a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity and is also a highly potent antagonist of 5-HT1a receptors.
    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
    Functional (Non-ulcer) Dyspepsia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10001394
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study will be to determine the efficacy of s-pindolol in the treatment of FD (NUD), based on the patient’s global impression
    E.2.2Secondary objectives of the trial
    Secondary efficacy end-points will include:
    i) The change from baseline in patient’s global severity of illness scale compared to placebo.
    ii) The change from baseline in severity of gastrointestinal symptoms scale compared to placebo (upper abdominal pain/discomfort, upper abdominal fullness, early satiety, bloating, nausea, composite of all symptoms).
    iii) The change from baseline in Quality of Life (QOL) Assessment compared to placebo.
    iv) The use of rescue medication compared to placebo.


    Daily data for the patient global impression, patient’s global severity of illness scale, severity of gastrointestinal symptoms scale and rescue medication will be collected for observation purposes.

    Safety of AGI 001 in doses of 2.5mg, 5mg and 7.5mg t.i.d will be evaluated by assessing adverse events, abnormal laboratory values, heart rate and the mean seated and standing diastolic blood pressure compared to placebo.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Be aged 18-70 years
    2) Have pain/discomfort centred in the upper abdomen, which may be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea on a minimum of 8 days, which need not be consecutive within 8-14 days prior to the randomisation visit. A patient may be considered for randomisation at any time during the run-in period, provided they have had pain/discomfort centred in the upper abdomen on at least 8 days.
    3) Fulfil Rome II criteria (modified) for functional dyspepsia i.e. in the last three months symptoms were present often (at least three weeks, at least one day a week) of:

    a. Persistent or recurrent symptoms (pain or discomfort centred in the upper abdomen);
    b. May be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea; and
    c. No evidence of organic disease (including at upper endoscopy) that is likely to explain the symptoms; and
    d. 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).

    4) Provide signed written informed consent (Attachment 2).
    5) Must be able to make entries into a touch tone telephone diary on a daily basis.
    6) Must be willing to abstain from taking rescue medication in the run-in phase.
    E.4Principal exclusion criteria
    A potential participant may be excluded from the study if he/she:

    1) Has gastroesophageal reflux disease:

    a. Known heartburn as the predominant symptom and/or
    b. Responds to proton pump inhibitors

    2) Has H. pylori infection (can be enrolled if eradicated at least 3 months prior to enrolment and patient is negative for H. pylori at this time). The urea breath test or the CLO™ test will be used to test for H. pylori infection.
    3) Has an identifiable cause, past or current for the symptoms, where if the disease improves or is eliminated, symptoms also improve. This will be assessed by endoscopy performed within 12 months prior to the randomisation visit, providing there has been no change in the patient’s symptoms during this period and will include: oesophageal, gastric or duodenal cancer, chronic peptic ulcer, oesophagitis (grade 2 or above), oesophageal ulceration or stricture or Barrett’s oesophagitis and evidence of prior oesophageal, gastric or duodenal surgery.
    4) Presence or history of biliary tract disease, pancreatitis, colitis, inflammatory bowel disease, irritable bowel syndrome.
    5) Requires immediate investigation, such as anaemia, unexplained weight loss, abdominal mass on abdominal examination, melaena, dysphagia, haematemesis or first presentation of symptoms in a patient over 50.
    6) Has past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy.
    7) Is pregnant or lactating. Women of childbearing potential must maintain effective contraception (See Section 5.4).
    8) Uses drugs judged by the Investigator to be the cause of the current episode of dyspeptic symptoms.
    9) Needs regular treatment with non-steroidal anti-inflammatory drugs within one month prior to commencing the study.
    10) Uses daily continuous treatment with omeprazole or other proton pump inhibitors, H2-receptor antagonists, prokinetic agents, mucosal preparations, prostaglandin analogues, anticholinergics or drugs likely to alter 5-HT metabolism (e.g. 5-HT reuptake inhibitors, monoamine oxidase inhibitors), bismuth containing drugs within one month prior to commencing the study.
    11) Has evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants.
    12) Has past or present alcohol or drug abuse in the opinion of the Investigator.
    13) Has any evidence of cardiovascular disease or is taking any medication active on the cardiovascular system, apart from stable low dose (< 75 mg orally/day) aspirin as prophylaxis.
    14) Has bronchial asthma
    15) Has participated in any other clinical trial within the last month.
    16) Has shown previous intolerance/sensitivity to the study medication.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the percentage of responders to s-pindolol compared to placebo based on the patient’s global impression.
    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 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) 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
    Dose escalation
    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.8.5The 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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 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 2005-02-07. 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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)
    Not different from the expected normal treatment of this 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 Decision2005-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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