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    Summary
    EudraCT Number:2006-002632-21
    Sponsor's Protocol Code Number:VRA107438
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-002632-21
    A.3Full title of the trial
    A double-blind, randomised, placebo controlled, single dose, two-period crossover study to investigate the therapeutic potential of the TRPV1 antagonist SB-705498 in treatment of subjects with rectal hypersensitivity including irritable bowel syndrome.
    A.4.1Sponsor's protocol code numberVRA107438
    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 SponsorGlaxoSmithKline Research & Development
    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 nameSB-705498
    D.3.4Pharmaceutical form Film-coated 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    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 placeboFilm-coated tablet
    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
    Rectal Hyperalgesia (in patients with irritable bowel syndrome and feacal urgency)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10038072
    E.1.2Term Rectal pain
    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 effects of a single dose of SB-705498 on rectal pain thresholds and ongoing pain in patients with rectal hypersensitivity associated with faecal urgency (Group 1) and IBS (Group 2)
    E.2.2Secondary objectives of the trial
    To further investigate efficacy and improvements in symptoms and quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Group 1 (Faecal Urgency) Patients.
    A subject will be eligible for inclusion in this study only if all of the following criteria
    apply:
    • Female or male subjects aged 18 to 65. Women may be of child bearing potential or
    of non-child bearing potential. Women of child bearing potential must use an
    effective method of contraception (see below).
    • Females of non-child bearing potential are defined as:
    • Post-menopausal females, being amenorrhoeic for at least 2 years with an
    appropriate clinical profile, e.g., age appropriate, history of vasomotor
    symptoms. However, if indicated this should be confirmed by oestradiol and
    FSH levels consistent with menopause (according to local laboratory ranges).
    • Pre-menopausal females with a documented hysterectomy (medical report
    verification) and/or bilateral oophorectomy. In the case of oophorectomy alone,
    only when the reproductive status of the woman has been confirmed by follow
    up hormone level assessment.
    • Faecal urgency, increased stool frequency, faecal incontinence and rectal
    hyperalgesia as defined by Chan et al., 2003, with no previous diagnosis of IBS.
    • Pre-study screening and baseline ECG, which, in the opinion of the Principal
    Investigator has no abnormalities that will compromise safety in this study.
    • Clinical laboratory tests at screening showing no clinically significant abnormalities
    in the opinion of the Principal Investigator.
    • Signed and dated written informed consent prior to admission to the study.
    • Able to understand and comply with protocol requirements, instructions and
    protocol-stated restrictions.
    • If on anti-diarrhoeal medications for faecal urgency / frequency, these have to be at a stable dose for 2 weeks prior to randomisation. In addition, anti-diarrhoeal
    medications which are opioids have to be non-systemically absorbed (e.g. loperamide is permitted if on a stable dose for 2 weeks prior to randomisation but not codeine phosphate).

    Inclusion Criteria for Group 2 (Irritable Bowel Syndrome) Patients
    A subject will be eligible for inclusion in this study only if all of the following criteria
    apply:
    • Female or male subjects aged 18 to 65. Women may be of child bearing potential or
    of non-child bearing potential (as defined for Group 1). Women of child bearing
    potential must use an effective method of contraception (see 5.2.3 Exclusion Criteria
    for Groups 1 and 2).
    • Has irritable bowel syndrome (IBS) as defined by Rome II criteria [Appendix 3,
    Drossman, 2000],
    • Has rectal hyperalgesia as defined by Chan et al., 2003 and determined using the
    protocol outline in barostat study published by Cremonini et al in 2005.
    • Pre-study screening and baseline ECG, which, in the opinion of the Principal
    Investigator has no abnormalities that will compromise safety in this study.
    • Clinical laboratory tests at screening showing no clinically significant abnormalities
    in the opinion of the Principal Investigator.
    • Signed and dated written informed consent prior to admission to the study.
    • Able to understand and comply with protocol requirements, instructions and
    protocol-stated restrictions.
    • If on anti-diarrhoeal medications or laxatives for control of bowel habit, these have
    to be at a stable dose for 2 weeks prior to randomisation
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria
    apply:
    • Other GI or pain conditions that in the opinion of Investigator may interfere with
    study procedures or confound data interpretation.
    • Any clinical or biological abnormality found at screen (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically
    significant [e.g., major depression (within the past 3 months)].
    • Any concurrent illness or disability that may affect the interpretation of clinical
    efficacy and/or safety data or otherwise contraindicates participation in this clinical
    study (i.e., current malignancy, HIV, significant mental illness).
    • History of alcohol, substance or drug abuse within the last year.
    • Uncontrolled hypertension at the Screening Visit, defined as persistent (after 3
    readings) systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg;
    measured after 5 min supine rest.
    A history or presence of multiple cardiovascular risk factors such as, but not limited
    to family history, myocardial infarction, coronary artery disease, vasospastic angina,
    heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease,
    including transient ischemic attack, stroke or peripheral arterial disease.
    • QTcB > 430 msec for men or > 450 msec for women on screening 12-lead ECG.
    • Participation in a trial with a new chemical entity within 3 months before the start of
    the study or participation in any other research trial within 30 days prior to the first
    dose of current study medication.
    • A history of drug or other allergy or any other reason that, in the opinion of the
    physician responsible, contraindicates their participation.
    • Unable to withdraw from analgesic medications for their rectal hyperalgesia (opioiddependent patients can be included if they are willing to withdraw from their opiate medication with a nineteen day washout period).
    • Unable / unwilling to refrain from taking the prohibited medications during the study
    • An unwillingness of male subjects to abstain from sexual intercourse with pregnant
    or lactating women from the time of the first dose of study medication until five halflives (nineteen days) following administration of the last dose of study medication.
    • An unwillingness of the male subject to use a condom/spermicide in addition to
    having their female partner use another form of contraception such as IUD,
    diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal
    implants or a tubal ligation if the woman could become pregnant from the time of the
    first dose of study medication until 84 days following administration of the last dose
    of study medication.
    • Female subjects who are pregnant, breast feeding, or have a positive serum
    pregnancy test or a positive urine pregnancy test either at screening or pre-dose on
    each dosing session.
    • An unwillingness of the female subject to use an appropriate form of contraception.
    Appropriate forms of contraception are defined as:
    a. Abstinence – The lifestyle of the female should be such that there is complete
    abstinence from intercourse from at least the commencement of their last normal
    period prior to the first dose of study medication and to continue until the first
    normal period (defined as normal for the woman, both in terms of duration and
    quantity of menses) after treatment or 15 days after the last dose of medication,
    whichever is the longest.
    b. One of the following methods is acceptable as the sole method of contraception if
    there is indisputable data that it is >99% effective otherwise it should be used with a
    barrier method (condom or occlusive cap {diaphragm or cervical/vault caps} used
    with spermicidal foam/gel/film/cream/suppository):
    • Established use of oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first dose of study medication. Subjects using hormonal contraception should use a barrier method in addition from the first dose of study medication
    until their next normal period following the end of the study.
    • Documented tubal ligation.
    • Documented placement of an intrauterine device (IUD) or intrauterine system
    (IUS).
    • Male partner sterilisation (vasectomy) prior to the female subject's entry into the
    study and is the sole partner for that female subject.
    • condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal
    foam/gel/film/cream.
    E.5 End points
    E.5.1Primary end point(s)
    VAS Pain score to rectal distensions (at 12, 24, 36 and 48mmHg above baseline
    operating pressure threshold) pre-dose and 6 hrs post-dose.
    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 Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) Information not present in EudraCT
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    As SB-705498 is not a licensed drug, no further treatment will be provided after the end of this trial. However, standard medical care will be provided
    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 Decision2006-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-22
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