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    Summary
    EudraCT Number:2005-004157-99
    Sponsor's Protocol Code Number:F1D-MC-HGLQ
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-07
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-004157-99
    A.3Full title of the trial
    F1D-MC-HGLQ A Randomized, Open-Label Study Comparing the Effects of Olanzapine Pamoate Depot with Oral Olanzapine on Treatment Outcomes in Outpatients with Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    HGLQ
    A.4.1Sponsor's protocol code numberF1D-MC-HGLQ
    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 SponsorEli Lilly and Company 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 nameOlanzapine Pamoate Depot
    D.3.2Product code LY170053 Compound 426906
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlanzapine
    D.3.9.1CAS number 221373-18-8
    D.3.9.3Other descriptive nameolanzapine pamoate Depot
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number405
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name ZYPREXA 5 mg coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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.3.4Pharmaceutical form
    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 INNolanzapine
    D.3.9.1CAS number 132539-06-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    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
    The primary objective of the study F1D-MC-HGLQ is to assess the time to all-cause discontinuation in outpatients with schizophrenia who are at risk for relapse, as demonstrated by at least two episodes of clinical worsening in the past 24 months such that the patient was hospitalized or required an increased level of care surrounding the episode. Patients will be treated with either OPD or oral olanzapine for up to 104 weeks of treatment.
    E.2.2Secondary objectives of the trial
    to assess the difference(s) between OPD and oral olanzapine on:
    · health outcome measures
    · patient satisfaction of treatment
    · the incidence of all-cause discontinuations
    · the time to relapse
    · the incidence of patients experiencing a relapse
    · the change from baseline to endpoint in efficacy scale scores, Clinical Global Impression – Severity of Illness (CGI-S) and Positive and Negative Syndrome Scale (PANSS) total and subscale scores including the Brief Psychiatric Rating Scale (BPRS)
    · the safety and tolerability of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    [1] Male or female patients aged at least 18 and no more than 65 years.
    [2] All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
    [3] Patients must have schizophrenia that meets disease diagnostic criteria as defined in the DSM-IV or DSM-IV-TR (Sections 295.10, 295.20, 295.30, 295.60, or 295.90) and must be an outpatient at the time of study entry and randomization.
    [4] Patients must:- have a CGI-S score d4 at Visits 1 and 2- have a PANSS score <70 at Visits 1 and 2- be an outpatient who has not been hospitalized for psychosis in the 8 weeks prior to Visit 1. Day hospitalization is allowed.
    [5] Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol.
    [6] Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an ICD.
    [7] Patients who have experienced at least two episodes of clinical worsening of schizophrenia symptoms in the past 24 months such that hospitalization or an increased level of care surrounding the episode was required. Increased level of care can include the addition of or change to any of the following from a lower level of care: day hospital program; outpatient crisis management; short-term psychiatric treatment in an emergency room; or an addition, increase, or switch of medication. Medical history can be provided by patient, family member, or caregiver.
    [8] Patients with unsatisfactory clinical response or experiencing AEs or who are nonadherent on current antipsychotic therapy such that the patient and the treating physician desire to change the patient’s therapy.
    E.4Principal exclusion criteria
    [9] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
    [10] Are employed by Lilly Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility.
    [11] Have received treatment within the last 30 days with a drug that has not received regulatory approval for that indication at the time of study entry.
    [12] Patients who have previously completed or withdrawn from this study after randomization, or patients who have participated in previous OPD studies.
    [13] Patients who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, olanzapine orally disintegrating tablets, and/or OPD) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, who have exhibited a lack of efficacy/response to treatment, including treatment resistance, or who have a condition that would preclude use of a long-acting depot formulation.
    [14] Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (60 days) prior to Visit 2.
    [15] Patients with DSM-IV– or DSM-IV-TR–defined substance (except nicotine and caffeine) dependence within the past 30 days.
    [16] Patients who received treatment with remoxipride within 6 months (180 days) prior to Visit 2.
    [17] Patients who require concomitant treatment with any other medication with primarily central nervous system (CNS) activity, other than those allowed
    [18] Patients who are actively suicidal (for example, any suicide attempts within the past month [30 days] or any current suicidal intent, including plan) in the opinion of the investigator.
    [19] Patients with a history of allergic reaction to study drug(s) in any formulation.[20] Patients with known Human Immunodeficiency Virus positive (HIV+) status.
    [21] Female patients who are either pregnant or nursing.
    [22] Patients with known, uncorrected, narrow-angle glaucoma.
    [23] Patients who have experienced one or more seizures without a clear and resolved etiology.
    [24] Patients who have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis (absolute neutrophil count <500mm3) during the patient’s lifetime.
    [25] Patients with serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit (ICU) hospitalization for the disease is anticipated within 6 months.
    [26] Patients with acute, serious, or unstable medical conditions, including, but not limited to, inadequately controlled diabetes (glycated hemoglobin [HbA1c] >8%); severe hypertriglyceridemia (fasting triglycerides e500 mg/dL); hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accident (CVA); uncontrolled seizure disorders; serious acute systemic infection orimmunologic disease; unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (specificallycurrent absolute neutrophil count <1,500 mm3).
    [27] Patients who received treatment with clozapine within 6 months prior to Visit 1.[28] Patients with alanine transaminase (ALT/SGPT) values e2 times the upper limit of normal (ULN) of the performing laboratory, or aspartate transaminase (AST/SGOT) values e3 times the ULN, or total bilirubin values e1.5 times the ULN at Visit 1.
    [29] Patients not being treated with an antipsychotic drug known to elevate prolactin with a prolactin level >200 ng/mL; and patients presently treated with antipsychotic drugs (including risperidone) known to elevate prolactin levels with a prolactin level >300 ng/mL at Visit 1.
    [30] Patients with a diagnosis of Parkinson’s disease, dementia-related psychosis, or related disorders. If a patient has a past misdiagnosis of Parkinson’s disease, dementia-related psychosis, or related disorders, the investigator will need to contact the Lilly clinical research physician/scientist (CRP/CRS) prior to enrollment.[31] Patients with a QTc (using Bazett’s method) >450 msec (male) or >470 msec (female), as read by the central vendor cardiologist. If the primary investigator disagrees with the interpretation, the Lilly CRP or CRS must be consulted before the patient is allowed to enter the study.
    E.5 End points
    E.5.1Primary end point(s)
    Time to all-cause discontinuations represents the most conservative method of measuring patient relapse as it assumes that all discontinuations are potentially related to treatment efficacy but may not be reported as such. This method is well suited to a real-world treatment outcomes study as it captures not only discontinuations due to poor clinical outcomes but also discontinuations related to tolerability, safety, and patient satisfaction. All reasons for discontinuation other than “protocol completed” will be tabulated as part of the all-cause discontinuation analysis. Cases discontinued due to sponsor decision will be treated as censored data in order to minimize potential bias of the results
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.7.1.3.1Other trial type description
    Phase IIIb
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Oral olanzapine
    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
    As per protocol
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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 2006-02-07. 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 158
    F.4.2.2In the whole clinical trial 572
    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 per protocol
    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 Decision2006-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-29
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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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