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    Summary
    EudraCT Number:2008-000406-36
    Sponsor's Protocol Code Number:ESZ111503
    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:2008-04-25
    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 number2008-000406-36
    A.3Full title of the trial
    A randomised, double-blind, double-dummy, placebo-controlled, 3-way crossover study to evaluate potential next-day residual effects of a single evening dose of 3mg eszopiclone and 7.5mg zopiclone in healthy adult subjects.
    A.4.1Sponsor's protocol code numberESZ111503
    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 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 nameEszopiclone
    D.3.2Product code GSK1755165
    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.3.9.2Current sponsor codeGSK1755165
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.0
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Zimovane
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZopiclone (Zimovane)
    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.3.9.3Other descriptive nameZopiclone (Zimovane)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    None
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the existence and time course of potential next-day residual psychomotor effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo as measured by the mean tracking error of the Continuous Tracking Test (CTT).
    E.2.2Secondary objectives of the trial
    • To evaluate the next day effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo on psychomotor performance, memory, and attention as measured using the CTT, Digit Symbol Substitution Test (DSST), N-Back tasks, and Critical Flicker Fusion (CFF).
    • To evaluate the next day effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo on subject-reported sedation, mood, and coordination as measured using Linear Analogue Rating Scales (LARS).
    • To evaluate the overall safety and tolerability of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide written informed consent.
    2. Aged 25 to 40 years (inclusive).
    3. In good health as determined by medical and psychiatric history, physical examination, and serum chemistry, haematology, and urinalysis results
    E.4Principal exclusion criteria
    1) Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (myasthenia gravis of particular concern), immunological, or haematological disease or abnormality, as determined by the study physician.
    2) Pregnant or lactating females and females of child-bearing potential not using effective contraception. A female of childbearing potential must have a negative serum pregnancy test result at Visit 1 and must be using an acceptable method of birth control for a duration that is in accordance with the product label, or, for non-product methods, as determined by the investigator, prior to entry into the study and throughout the study. Methods that meet the GSK definition of highly effective (i.e. having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label) are:
    • Oral contraceptives, either combined or progestogen only; injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; or percutaneous contraceptive patches.
    • Intrauterine Device (IUD) or intrauterine system (IUS) that meets the above definition of effectiveness as stated in the product label.
    • Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject. For this definition, “documentation” refers to the outcome of the investigator's/designee’s verbal interview with the subject.
    • Double-barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository).
    3) Symptoms/signs that are consistent with any sleep disorder, or a significant sleep irregularity as determined by the investigator and/or as detected during the screening PSG recording (Visit 2) e.g. apnoea-hypopnoea index of 10 or more per hour of sleep or Periodic Limb Movement with arousal of 10 or more per hour of sleep.
    4) Sleep/wake cycle (e.g. due to shift work, abnormal sleep timing or duration) as assessed via clinical history and actigraphy, that is liable to prejudice the outcome of the study.
    5) History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the 12 months preceding Visit 1.
    6) Smokes more than 5 cigarettes per day on average over the 1 month preceding Visit 1. [Please view protocol for further information].
    7) Positive urine drug screen (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates). A repeat test will not be allowed [Please view protocol for further information].
    8) Use of any psychotropic medications such as benzodiazepines, barbiturates and narcotics, or other medications, including over the counter (OTC) and herbal products that may affect sleep/wake function, within the 3 months preceding Visit 1, or a need to use any of these medications during the study.
    [Please view protocol for further information]
    9) Positive alcohol breath test. A repeat test will not be allowed.
    [Please view protocol for further information].
    10) Females who consume more than 2 units of alcohol per day, or males who consume more than 3 units of alcohol per day, on average over the 1 month preceding Visit 1.please view protocol for further information.
    11) Consumption of beverages containing a total 300 mg or more per day on average of caffeine or other xanthines (e.g., coffee, cola, tea, chocolate) over the 1 month preceding Visit 1.[please view protocol for further information].
    12) Use of any other medication within the 2 weeks preceding Visit 1, with the exception of contraceptives (as described above), cold, flu or hay fever remedies (as described above) non-steroidal analgesics, and paracetamol.
    13) Any laboratory abnormality (refer to SPM for local laboratory reference ranges) that in the investigator’s judgment is considered to be clinically significant and that is not resolved (a test may be repeated once only) by the screening PSG visit (Visit 2).
    14) Known seropositivity for human immunodeficiency virus (HIV), or active Hepatitis B or C infection.
    15) Known hypersensitivity to any of the study medications, or their excipients, (please view protocol for further information).
    16) Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
    17) Body mass index of less than 18, or more than 30, or a total body weight of less than 50 kilograms.
    18) Currently participating in another clinical trial in which the subject is, or will be, exposed to an investigational or non-investigational drug or device, or has done so within the 3 months preceding Visit 1.
    19) In the opinion of the investigator, will be noncompliant with the visit schedule or study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Mean Tracking Error assessed during the CTT. The primary analysis will be performed on the mean of the 5 assessments conducted 7.5, 8, 8.5, 9 and 9.5 hours post dose (double blind).
    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 Information not present in EudraCT
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Double Dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 years0
    E.8.9.1In the Member State concerned months5
    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 months5
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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 Decision2000-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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