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    Summary
    EudraCT Number:2007-003553-82
    Sponsor's Protocol Code Number:AGI003-003 (ARDIS-1)
    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:2007-08-23
    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 number2007-003553-82
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study of AGI-003 (Arverapamil) in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D)
    A.3.2Name or abbreviated title of the trial where available
    ARDIS-1
    A.4.1Sponsor's protocol code numberAGI003-003 (ARDIS-1)
    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 Research Ltd
    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 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 nameAGI-003 Immediate Release Tablets
    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 38176-02-2
    D.3.9.2Current sponsor codeAGI003
    D.3.9.3Other descriptive nameArverapamil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    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 nameAGI-003 Immediate Release Tablets
    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 38176-02-2
    D.3.9.2Current sponsor codeArverapamil
    D.3.9.3Other descriptive nameAGI-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    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 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 Information not present in EudraCT
    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 with Diarrhea (IBS-D)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060845
    E.1.2Term Diarrhea predominant irritable bowel syndrome
    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 and safety of AGI-003 (arverapamil) in the treatment of IBS-D during an active phase of diarrhea based on the patient’s global impression of adequate relief.
    E.2.2Secondary objectives of the trial
    Change from base line of symptoms associated with IBS-D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients, 18 to 75 years of age inclusive, meeting ROME III criteria for IBS-D, willing to abstain from taking rescue medication in the run in phase, and free of any cardiac contraindication to verapamil and who meet all the of the following inclusion/exclusion criteria.
    1) Age 18-75 years
    2) Fulfil ROME III criteria for IBS-D and at screening report their usual abdominal pain /discomfort score at no greater than 4 on the scale of 1-6.
    3) Provide signed written informed consent
    4) Must be able to make entries into a touch tone telephone diary on a daily basis
    5) Must be willing to abstain from taking rescue medication in the run-in phase
    6) Must be willing to abstain from eating grapefruit or drinking grapefruit juice for the treatment phase of the study
    If the patient meets the above criteria, then the criteria for randomization after the run-in period are the following:
    1) Be compliant in the use of IVRS for at least 11 of the run-in days.
    2) Has typical bowel movements on a minimum of 7 days and at least 50% of the run-in period days, e.g. 8 of 15 days reported as 5, 6 or 7 on the BSS with the IVRS.
    3) Has abdominal discomfort or pain on a minimum of 7 days and at least 50% of the run-in period days, which need not be consecutive. For the days when they report on IVRS their average pain score must be 0.5-4.0 on the pain scale.
    E.4Principal exclusion criteria
    1) During screening the patient reports their usual abdominal pain/discomfort score is 5 or 6 on a scale of 1-6
    2) Any evidence of cardiovascular disease or any other disease where treatment with verapamil is contra-indicated such as:
    • Severe left ventricular dysfunction
    • Hypotension (systolic pressure <90 mm Hg) or cardiogenic shock
    • Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
    • Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker)
    • Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes)
    3) Lactose intolerance as reported by the patient and patient is not currently abstaining from milk products or not taking lactase enzyme OTC products and for the duration of the study will not agree to continuing to abstain or will not agree to continue their OTC medication
    4) Coeliac disease (diagnosed using serology or duodenal biopsy)
    5) Unexplained fever or weight loss of at least 10 pounds during the last 6 months, or any clinically significant symptoms (e.g. rectal bleeding or a recent change in pattern of bowel habits, unless a pre-screening colonoscopy to eliminate any other diseases of the gastrointestinal tract might explain the symptoms)
    6) Abnormal screening lab tests assessed by the Investigator as clinically significant or within 3 months of the screening visit have had a positive stool cultures or abnormal proctoscopy/abdominal ultrasound requiring further investigation
    7) Presence of ongoing 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
    8) Prior gastroparesis diagnosis by a physician
    9) Barrett’s and/or Grade III esophagitis
    10) > 1 episode of vomiting per week within a month prior to screening
    11) Acute diverticulitis or a history of greater than 1 episode of diverticulitis
    12) History of chronic colitis or acute self-limiting colitis of any etiology within 5 years of the screening visit (e.g. ulcerative colitis, Crohn’s disease, collagen vascular disease, ischemic colitis, enteric infection)
    13) History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction, gastric banding or bariatric surgery
    14) History of laxative abuse as determined by the Investigator
    15) Gastroesophageal reflux disease that is not controlled by the use of stable doses of PPIs for at least 3 months prior to the screening visit
    16) Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony
    17) 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 2 or more occasions within 6 weeks prior to study enrolment (except blood from haemorrhoids)
    18) History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy)
    19) 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 (measured within 1 month of Screening Visit)
    20) Antibiotic use within 1 month prior to screening (except for prophylactic antibiotics for such conditions as acne, cystitis, urinary tract infections, etc). If the patient is on prophylactic antibiotics, the patient must be on a chronic stable dose for >3 months and willing to remain on a stable dose during the run-in period and throughout the study
    21) Abnormal colonoscopy within the last 5 years (except mild benign polyps, mild diverticula, haemorrhoids)
    22) Past or present disease likely to complicate the evaluation of the study treatment e.g. significant cardiovascular, renal or liver disease, or malignancy
    23) Pregnancy or lactation. Women of childbearing potential must maintain effective contraception
    24) Use of drugs judged by the investigator to be the cause of the current episode of symptoms
    25) Evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants
    26) On tricyclic antidepressants (TCA) or serotonin selective reuptake inhibitors (SSRI) dose that has not been stabilized for at least 3 months
    27) Past or present alcohol or drug abuse, in the opinion of the Investigator
    28) Participation in any other clinical trial within the last month.
    29) Previous intolerance/sensitivity to the study medication
    30) Receiving a concomitant excluded medication as listed in Section 7.4
    31) Not met the run-in criteria for randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the Global Impression Treatment Response from Day 1 through Day 56. Only patients who answer ‘yes’ to the following question (defined as Global Impression) at least 50% of the days (i.e., at least 28 out of the 56 days) will be classified as a responder - “Today, do you consider that you had adequate relief from your IBS symptoms?”
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Last visit of last subject.
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 1000
    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)
    Option to partipate in roll-over study
    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 Decision2007-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
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