Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37697   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-000848-24
    Sponsor's Protocol Code Number:SB-223412/068
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2004-09-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-000848-24
    A.3Full title of the trial
    An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects with Irritable Bowel Syndrome
    A.4.1Sponsor's protocol code numberSB-223412/068
    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 Limited
    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 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 nameTalnetant
    D.3.2Product code SB-223412
    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 INNTalnetant
    D.3.9.2Current sponsor codeSB-223412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTalnetant
    D.3.9.2Current sponsor codeSB-223412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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 (IBS)
    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 is to determine whether talnetant provides adequate relief of IBS pain and discomfort in any dose group compared to placebo and to determine the safety and tolerability in IBS subjects.
    E.2.2Secondary objectives of the trial
    1. Explore differentiation in response among subgroups of IBS patients (e.g., bowel subgroup, or gender subgroup).

    2. Obtain dose-response information for design of subsequent studies.

    3. Evaluate for positive treatment effects within bowel subgroups for secondary symptoms:
    a urgency
    b stool frequency
    c stool consistency
    d bloating (encompasses abdominal fullness or swelling)
    e a feeling of incomplete evacuation
    f straining during a bowel movement.

    4. Compare treatment groups for global improvement of IBS symptoms.

    5. Compare treatment groups for improvement of IBS pain or discomfort.

    6. Compare treatment groups for changes in bowel pattern.

    7. Provide data on the effect of talnetant on subjects’ quality of life.

    8. To estimate the plasma concentrations of talnetant in IBS patients and to characterize the relationship between plasma concentrations and response (adequate relief).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:

    1. The subject signs and dates a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications. (see Section 8.2 of the protocol)

    2. The subject must be a male or female at least 18 years of age at the time of the Screening Visit.
     If female; the subject must have a negative serum pregnancy test result prior to investigational product administration and is eligible to participate if one of the followinhg criteria apply:
    a Is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant)
     post-menopausal defined as one year without menses in the absence of hormone replacement therapy.
     sterilization (via hysterectomy or bilateral tubal ligation)
    b Is of child-bearing potential and agrees to commit to one of the protocol-approved contraceptive methods (below) consistently and in accordance with both the product label and the instructions of a physician. Subjects will use one of the following GSK acceptable contraceptive methods for at least one month prior to Screening, and should continue to use the same contraceptive method throughout the study (Week 12).
     oral birth control pills administered for at least one monthly cycle prior to investigational product administration and continue throughout the 8-week treatment phase and the 4-week follow-up phase
     Progesterone implanted rods (NORPLANT†) inserted for at least one month prior to the investigational product administration but not beyond the third successive year following insertion.
     an IUD, inserted by a qualified clinician, with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion)
     medroxyprogesterone acetate (DEPO-PROVERA†) administered for a minimum of one month prior to the investigational product administration and administered for one month following study completion
     complete abstinence from intercourse for two weeks prior to the investigational product administration, throughout the 8-week treatment phase, and the 4-week follow-up phase
     double barrier method comprised of a spermicide with either a condom or diaphragm.
     has a male partner who is sterile to female subject's entry into the study and is the sole sexual partner for that female subject.

    3. The subject has normal results from a flexible sigmoidoscopy or colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 2 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):
     If the subject is < 50 years of age and has not had a colonic examination within 2 years of the Screening Visit, a flexible sigmoidoscopy, flexible sigmoidoscopy plus barium enema, or colonoscopy must be performed.
     If the subject is > 50 years of age and has not had a colonic examination within 2 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.

    Colonic procedure results must be known prior to dispensing study medication.
    4. The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3.

    5. During the two-week screening phase, the subject must have documented an average IBS pain or discomfort score >1.5 (on a 5 point scale where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe).

    6. During the two-week screening phase, the subject must have conducted self-assessments on at least 12 days using the telephone data entry system.

    7. The subject is ambulatory (defined as not depending exclusively on a wheelchair for mobility).
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:

    1. Subject reported no stool for 7 consecutive days during the two-week screening phase.

    2. Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to):
     Current evidence, or history of (at any time in the past):
     inflammatory bowel disease (Crohn's disease or ulcerative colitis)
     laxative abuse (in the clinical judgement of the physician)
     gastrointestinal surgery (exceptions include greater than or equal to 6 months post-surgery appendectomy, cholecystectomy, fundoplication without gas bloat, or hiatal hernia repair; greater then or equal to 3 months post-surgery herniorrhaphy without bowel resection)
     gastroparesis
     GI malignancy
     carcinoid syndrome
     amyloidosis
     chronic pancreatitis
     gastrointestinal adhesions
     toxic megacolon
     gastrointestinal perforation
     gastrointestinal obstruction and/or stricture.
     Current evidence of or within the past 6 months:
     diverticulitis
     ileus
     symptomatic cholelithiasis
     proctitis.
     Current evidence of:
     Hemoccult (+) stool of unknown etiology.

    3. The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition).

    4. Mental impairment or inability or refusal to follow directions, inability to understand how to use the touch-tone telephone system, or inability or refusal to complete any of the study questionnaires.

    5. Current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected).

    6. Exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT), AST (SGOT), alkaline phosphatase or bilirubin values >2.0 times the upper limit of normal.

    7. Renal impairment as evidenced by a serum creatinine value >2.0 mg/dl.

    8. Strongly or mildly positive (>20 units) TTG IgA test for celiac sprue prior to randomization.

    9. Exhibits an abnormal creatine kinase value of greater than or equal to 5.0 times the upper limit of normal.

    10. Male subjects exhibit a total testosterone value of <7nmol/L (<200ng/dL)

    11. Exhibits an abnormal serum thyroid-stimulating hormone (TSH) value (If TSH has not been measured within the past three years, it must be assayed prior to randomization).

    12. Failure to discontinue of one (or more) prohibited concomitant medication(s) within 7 days prior to the Screening Visit as described in Section 8.2.

    13. Failure to remain on a stable dose of one (or more) permitted medication(s) for at least 30 days prior to the Screening Visit as detailed in Section 8.1.

    14. Use of an investigational drug, or participated in an investigational study within 30 days of the Screening Visit.

    15. History of hypersensitivity to quinolone antibiotics or quinolone derivatives.

    16. Diagnoses of a psychiatric disorder (DSM-IV) within the past two years that required hospitalization and/or involved a suicide attempt (e.g., major depression). Subjects diagnosed with a psychiatric disorder that did not require hospitalization or involve a suicide attempt must have remained on a stable dose of medication for at least six months prior to the Screening Visit.

    17. History of alcohol and/or substance abuse within the past two years.

    18. The subject is pregnant.

    19. The subject is breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with adequate relief of IBS pain and discomfort on all 4 of the last 4 weeks of the treatment phase.
    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 Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 Information not present in EudraCT
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    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 2004-09-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 670
    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)
    None
    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 Decision2004-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA