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    Summary
    EudraCT Number:2004-002752-34
    Sponsor's Protocol Code Number:Clin-AGI003-001
    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:2004-11-16
    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 number2004-002752-34
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AGI 003 IN THE TREATMENT OF NON-CONSTIPATION PREDOMINANT IRRITABLE BOWEL SYNDROME.
    A.4.1Sponsor's protocol code numberClin-AGI003-001
    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 003
    D.3.2Product code AGI 003
    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 INNR(+) Verapamil
    D.3.9.1CAS number 38176-02-02
    D.3.9.2Current sponsor codeAGI 003
    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 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 typeVerapamil HCl is a phenylalkylamine calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist)
    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
    Irritable bowel syndrome (not constipation predominant).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10023003
    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 r-verapamil in the treatment of IBS, based on the patient’s global impression, relief of abdominal discomfort / pain and use of rescue medication.
    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 (bloating/distension, stool frequency, urgency, composite of all symptoms).
    iii) The change from baseline in Bristol Stool Scale compared to placebo.

    Daily data from the patient global impression, patient severity of illness scale, severity of gastrointestinal symptoms scale, Bristol Stool Scale and the use of rescue medication will be collected for observation purposes.

    The safety of AGI 003 in doses of 20mg, 40mg and 80mg 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
    All patients must:
    1) Be aged 18-50 years
    2) Have abdominal discomfort or pain on at least 8 days, which need not be consecutive within 8-14 days of the randomisation visit. A patient may be considered for randomisation at any time during the run-in period, provided they have abdominal discomfort or pain on at least 8 days.
    3) Fulfil Rome II criteria (modified) for IBS i.e. in the last three months symptoms of abdominal discomfort or pain that has two out of these three features were present often (at least three weeks, at least one day a week):
    a. Relieved with defecation; and/or
    b. Onset associated with a change in frequency of stool; and/or
    c. Onset associated with a change in form (appearance) of stool.

    And
    None of the following symptoms:
    a. Fewer than three bowel movements a week;
    b. Straining during a bowel movement.
    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
    1) Any evidence of cardiovascular disease or taking of any medication active on the cardiovascular system, apart from stable low dose aspirin (< 75 mg orally/day) for prophylaxis.
    2) Lactose intolerance, whose lactose intolerance symptoms are not completely or substantially relieved solely by abstaining from dairy products. (Patients with lactose intolerance on a lactose free diet who qualify otherwise, may be enrolled).
    3) Celiac disease (Blood test to measure levels of antibodies (antigliadin, anti-endomysium, and antireticulin) to gluten).
    4) Unexplained fever or weight loss of at least 10 pounds during the last 6 months, or any clinically significant symptoms, e.g. patients with rectal bleeding or a recent change in pattern of bowel habits (unless they have had a pre-screening colonoscopy to eliminate any other diseases of the gastrointestinal tract that might explain the symptoms).
    5) Abnormal laboratory tests, positive stool cultures or abnormal proctoscopy / abdominal ultrasound which requires further investigation.
    6) Presence of organic disease of the gastrointestinal tract, liver, pancreas, biliary tree (e.g. gastritis, symptomatic gallstones, duodenal ulcer, gastroenteritis, diverticulitis or megacolon) with the exception of haemorrhoids, hiatus hernia and non-symptomatic gallstones.
    7) Functional dyspepsia.
    8) Any severe or intolerable upper GI symptoms (i.e. early satiety, postprandial fullness, sensation of prolonged digestion, nausea).
    9) Greater than one episode of vomiting per week.
    10) Moderate or severe diverticulosis, in the opinion of the Investigator.
    11) Acute diverticulosis or a history of greater than one episode of diverticulosis.
    12) History of chronic colitis of any aetiology (e.g. ulcerative colitis, Crohn’s disease, collagen vascular disease, ischaemic colitis). A subject with a history of acute self limited colitis can be included if otherwise qualified.
    13) Acute (currently active) colitis of any aetiology.
    14) History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction.
    15) History of laxative abuse as determined by the Investigator.
    16) Moderate, severe or intolerable gastroesophageal reflux disease or heartburn symptoms.
    17) Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony.
    18) History of gastrointestinal bleeding based on clinical judgement that would interfere with the subject’s safety or with the efficacy assessments of the study, or if the subject has had gastrointestinal bleeding on two or more occasions within six weeks prior to study enrolment (with the exception of blood from haemorrhoids).
    19) History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy).
    20) Presence of pathogenic parasites, ova, bacteria or any occult blood in stools which in the opinion of the Investigator may be responsible for GI symptoms (if measured within one month of Visit 1).
    21) Antibiotic use within one month prior to Visit 1 (except for prophylactic antibiotics for such conditions as acne, cystitis, UTI’s etc. (must be on a chronic stable dose for > 3 months).
    22) Abnormal colonoscopy within the last five years (with the exception of mild benign polyps, mild diverticula, haemorrhoids).
    23) Any other past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy.
    24) A family history of colorectal cancer - these should be properly evaluated.
    25) Pregnancy or lactation. Women of childbearing potential must maintain effective contraception (See Section 5.4).
    26) Use of drugs judged by the investigator to be the cause of the current episode of symptoms.
    27) Evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants (See Section 7.5).
    28) Past or present alcohol or drug abuse, in the opinion of the Investigator.
    29) Participation in any other clinical trial within the last month.
    30) Has shown previous intolerance/sensivity to the study medication.
    E.5 End points
    E.5.1Primary end point(s)
    The first primary endpoint is the difference in the percentage of responders between active and placebo based on the patient’s global impression.

    The second primary endpoint is the difference in the percentage of responders between active and placebo based on the relief of the patient’s abdominal pain/discomfort.

    The third primary endpoint is the use of rescue medication (loperamide, paracetamol) during the study compared to placebo.
    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) 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 2004-11-16. 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 state90
    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 Decision2004-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
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