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    Summary
    EudraCT Number:2004-003880-61
    Sponsor's Protocol Code Number:060-CL-305
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-22
    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 ConcernedEstonia - SAM
    A.2EudraCT number2004-003880-61
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE POTENTIAL EFFICACY, SAFETY AND TOLERABILITY OF DIFFERENT ORAL DOSES OF YM060 IN PATIENTS WITH DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME
    A.3.2Name or abbreviated title of the trial where available
    Gloria
    A.4.1Sponsor's protocol code number060-CL-305
    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 SponsorYamanouchi Europe B.V.
    B.1.3.4CountryNetherlands
    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 nameramosetron hydrochloride
    D.3.2Product code YM060
    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 INNramosetron
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5, 5, 10, 20
    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 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
    diarrhea-predominant irritable bowel syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    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
    To investigate the potential efficacy, safety and tolerability of different oral doses of YM060 in patients with diarrhea-predominant irritable bowel syndrome
    E.2.2Secondary objectives of the trial
    To identify dose(s) for future phase III clinical studies
    To obtain data on population pharmacokinetics
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At study entry (visit 1):
    1. Patient who signs written informed consent.
    2. Male or female patient aged between 18-70 years.
    3. a. Patient meets Rome II criteria for IBS(2) , i.e.: at least 3 weeks or more, which need not be consecutive, in the preceding 3 months of abdominal discomfort or pain that has two out of three following features:
    (1) Relieved with defecation; and/or
    (2) Onset associated with a change in frequency of stool; and/or
    (3) Onset associated with a change in form (appearance) of stool
    b. Patient is identified as having d-IBS, i.e.: one or more of question 2, 4 or 6 from the Questions and Rules to Identify d-IBS Patient (Appendix 5) are rated 2 or above, and questions 1, 3 and 5 are rated 0 or 1.
    4. Patient in whom organic disease has been ruled out after being diagnosed with IBS, within 5 years prior to the run-in, by a sigmoidoscopic (for patients <50 yrs), colonoscopic (for patients ³50 yrs) or contrast-enema examination. Source documentation must be obtained as evidence. However, IBS patients with benign polyps or colonic diverticulosis which is judged to have no influence on the digestive tract passage are acceptable
    5. Regarding stool form, the patient’s main complaint is diarrhea
    At randomization (visit 2):
    6. Patient who answered all daily questions for at least 5 days per week, and answered all the weekly questions during the 2-week run-in period
    7. Patient whose average daily scores of abdominal discomfort or pain are greater than 0.7 based on a 5-point severity scale during the run-in period
    Abdominal discomfort/pain severity score:
    0: None, 1: mild, 2: moderate, 3: severe, 4: intolerable
    E.4Principal exclusion criteria
    Patient will be excluded from participation if any of the following apply:

    At study entry (visit 1):
    1. Patient with a history of surgical resection of the stomach, small intestine or large intestine (excluding resection of the appendix or benign polyps)
    2. Patient with a history of inflammatory intestinal diseases (Crohn’s disease or ulcerative colitis)
    3. Patient with a history of ischemic colitis
    4. Patient with infectious enteritis
    5. Patient with any disease, other than IBS, potentially affecting the digestive tract passage or colonic function
    6. Patient requiring treatment with any of the non-permitted drugs which has not been safely stopped 3 days prior to the 2-week run-in period
    7. Patient who has a history of drug or alcohol abuse within 1 year prior to the start of this clinical trial
    8. Patient with malignant melanoma and any non-skin malignancy within 5 years prior to the start of this clinical trial
    9. Patient with thyroid dysfunction
    10. Patient receiving radiotherapy for abdominal disease
    11. Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
    12. Female of child-bearing potential without using a medically acceptable method of birth control (medically acceptable methods of birth control are: intra-uterine devices, vaginal device, contraceptive pills of combination type, contraceptive patch, barrier method, hormonal implants and injectable contraceptives, or female being surgically sterile or being at least 1-year postmenopausal)
    13. Pregnant woman or lactating mother or woman with an intention of pregnancy
    14. Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to visit 1
    15. Known allergy to the study drug, any of its components or any other 5-HT3 antagonists.
    16. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study
    17. Employee of the Yamanouchi Group or CRO involved in the study

    At randomization (visit 2):
    18. Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period (see Appendix 6 for the detailed description and illustration of the Bristol Stool Form Scale).
    19. Patient with fewer than three bowel movements per week in the 2-week run-in period
    20. Pregnant woman as determined by the positive pregnancy test result
    21. Patient who has recently experienced lactose intolerance.
    22. Patient with abnormal laboratory test or positive stool cultures (e.g., C. difficile, ova and parasites, Camplylobacter, E. Coli 0157:H7, Yersinia, Salmonella, Shigella), which is judged to be clinically significant.
    23. Patient who takes contraindicated concomitant drugs (see Appendix 1)
    E.5 End points
    E.5.1Primary end point(s)
    · Responder rate of global assessment of relief of overall IBS symptoms during the last 4 weeks of treatment

    · Responder rate of global assessment of relief of abdominal discomfort/pain during the last 4 weeks of treatment

    Definitions of responder:
    IBS symptoms relief: Patient-reported Global assessment of relief of overall IBS symptoms (question #10 in Appendix 4) with a score of 0 or 1 for at least 2 weeks of the last 4 weeks treatment.
    Abdominal discomfort/pain relief: Patient-reported Global assessment of relief of abdominal discomfort/pain (question #11 in Appendix 4) with a score of 0 or 1 for at least 2 weeks of the last 4 weeks of treatment.
    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 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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 No
    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 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 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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 2005-02-22. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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 Decision2005-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
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