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    Summary
    EudraCT Number:2009-011855-40
    Sponsor's Protocol Code Number:OTB109059
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-011855-40
    A.3Full title of the trial
    A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation.
    A.4.1Sponsor's protocol code numberOTB109059
    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 and Development Ltd
    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 nameGSK557296
    D.3.2Product code GSK557296
    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.3.9.2Current sponsor codeGSK557296
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboTablet
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature ejaculation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036596
    E.1.2Term Premature ejaculation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if an on demand dosing of 50 or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of IELT during an 8 week study period compared to placebo in men with premature ejaculation.
    E.2.2Secondary objectives of the trial
    1. To assess safety and tolerability of 50 mg and 150 mg of GSK557296.
    2. To assess change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment
    3. To characterize the pharmacokinetics of GSK557296 in men with premature ejaculation.
    4. To characterize the dose/exposure response relationship using PK/PD modeling, as data permit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males with primary PE, according to the ISSM Consensus Definition (a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy)
    2. Stable heterosexual relationship, with a single non pregnant, nonlactating female partner using adequate contraception (as confirmed by oral questioning of male study subject) in a relationship of greater than >4 months duration. This same partner will be the one with whom the subject makes and records all IELT attempts during the duration of the study.
    3. Aged between 18 and 50 years (i.e. subjects must not have completed their 50th year birthday at the time of screening).
    4. The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period
    5. The average intravaginal ejaculatory latency time must be <65 seconds based on the study-provided stop watch assessments
    E.4Principal exclusion criteria
    - Positive pre-study Hepatitis B surface antigen or Hepatitis C antibody
    result and HIV antibody and or confirmatory ELISA test at screening.
    - History of liver disease, or known hepatic or biliary abnormalities
    (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    - Erectile dysfunction (IIEF-EF domain score < 22)
    - Active/recent (< 6 months) prostatitis (symptoms or treatment seeking for newly diagnosed or flare of symptoms related to previously diagnosed prostatitis).
    - Any unstable medical, psychiatric or substance abuse disorder.
    - Penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s
    disease) that would significantly impair sexual performance.
    - Prior implantation of penile implant for erectile dysfunction
    - Primary hypoactive sexual desire.
    - Spinal cord injury.
    - History of seizures, within last 6 months.
    - History of prostate cancer treated or untreated.
    - History of prostatectomy or prostate procedures for any cause.
    - Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia.
    - Significant active peptic ulceration.
    - Presence of the following conditions prior to screening: myocardial infarction,
    coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically
    evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
    - Cardiac arrhythmia (as defined in protocol)
    - History of congenital QT prolongation and/or QTc interval >450msec at screening
    visit (Visit 1) using the Bazett formula.
    - Mean diastolic/systolic cuff BP > 90/140 mmHg at the screening visit.
    - History of malignancy within the past five years (other than squamous or basal cell skin cancer).
    - Any condition which would preclude sexual activity.
    - Concomitant medications used within 7 days of Visit 1 and or at any time
    during the study
    - Subjects who have received any investigational drug (including placebo) within 30
    days of the screening visit or 5 half lives of the investigational drug whichever is
    longer.
    - Abnormal laboratory values:
    - Serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory (obtained in the morning vs in the afternoon).
    - Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges.
    - Clinically significant elevation of AST (of > 126) and/or ALT (of > 144).
    - Screening PSA value outside the country specific normal reference ranges
    - TSH outside the country specific normal reference ranges at visit 1.
    - Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
    - Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
    - Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe
    (Child-Pugh C) hepatic impairment.
    - Known hypersensitivity to GSK557296 or any component of the
    investigational medication.
    - Subjects who are illiterate or unable to understand the questionnaires or the subject diary.
    - Subjects who are unwilling or unable to complete the subject diary.
    - Subjects who are unwilling to be randomized to placebo.
    - Subject whose sexual partner is actively trying to conceive, and or is unwilling to use a reliable form of birth control as outlined in Section 8.1 for the duration of the trial. Or whose female partner is breast feeding.
    - Subjects, who in the opinion of the investigator, would be non-compliant with the
    majority of the visits scheduled or study procedures.
    - History of sensitivity to heparin or heparin-induced thrombocytopenia (for subjects
    at sites where PK studies are planned).
    - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or
    nicotine-containing products within 1 month prior to screening.
    - Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos,
    exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first
    dose of study medication, and for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Intravaginal ejaculatory latency time: Time from vaginal penetration (start stopwatch) until ejaculation (stop stopwatch), assessed after every attempt at intercourse with 50mg, 150 mg GSK557296 or placebo therapy, compared over all 8 weeks of treatment or until premature discontinuation.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    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
    Not applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 75
    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 applicable.
    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 Decision2009-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
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