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    The EU Clinical Trials Register currently displays   37950   clinical trials with a EudraCT protocol, of which   6228   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-003519-33
    Sponsor's Protocol Code Number:D1443L00003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-16
    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
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-003519-33
    A.3Full title of the trial
    RAPID - An Open-Label, Randomised, Multicentre Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immedicate Release), over 14 days, in Acute Schizophrenia / Schizoaffective Disorder (Rapid versus Covential Titration).
    A.3.2Name or abbreviated title of the trial where available
    RAPID
    A.4.1Sponsor's protocol code numberD1443L00003
    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 SponsorAstraZeneca UK 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 Yes
    D.2.1.1.1Trade name Seroquel IR Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    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 nameSeroquel IR Tablets
    D.3.2Product code PL 17901/0038-0041 & PL 17901/0088
    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.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Schizophrenia and Schizoaffective Disorder
    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 objectives of this study are to evaluate the efficacy and tolerability of quetiapine IR (Immediate Release), over 14 days, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration up to a maximum daily dose of 800 mg.

    The primary objective of this study is to compare the efficacy of quetiapine IR, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration, by assessment of Positive and Negative Syndrome Scale (PANSS) at Day 7.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:

    1. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by assessment of PANSS at Day 5 and 14.

    2. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by evaluation of PANSS excitatory subscale (PANSS-EC) at Day 5, 7 and 14.

    3. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by evaluation of PANSS negative, positive and general subscales at Day 5, 7 and 14.

    4. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by assessment of Clinical Global Impression – Severity (CGI-S) and Clinical Global Impression – Improvement (CGI-I) at Day 5, 7 and 14.

    5. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of vital signs and the frequency and severity of adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study treatment phase, subjects must fulfil all of the following criteria:
    1. Provision of informed, written consent (or relative or carer assent, if the subject has been assessed as not capable of providing informed, written consent).
    2. Male or female, aged 18-65 years.
    3. In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia or schizoaffective disorder (according to DSM-IV diagnostic criteria).
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. In-patients who, it is anticipated, will be discharged before the end of the titration period (Day 4).
    2. Subjects who are considered to be treatment resistant to antipsychotic medication, according to the Kane criteria (Kane et al 1988) (i.e. lack of significant symptom relief after two standard antipsychotic medications, from different classes, after 6 weeks of treatment with a dose equivalent to chlorpromazine 1000 mg per day).
    3. Subjects with relevant clinical disease (renal or hepatic impairment; cardiovascular disease or cerebrovascular disease; diabetes mellitus or risk factors for the development of diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator.
    4. History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator.
    5. Clinically abnormal ECG at Visit 1 as determined by the Investigator.
    6. An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter at Visit 1.
    7. Administration of concomitant antipsychotic medication during the study including, but not limited to, the following:
    · Atypical antipsychotics: amisulpride, aripiprazole, clozapine, olanzapine, risperidone and zotepine
    · Typical antipsychotics: chlorpromazine, fluperitixol, fluphenazine, haloperidol, levomepromazine, pericyazine, perphenazine, pimozide, pipotiazine, prochlorperazine, sulpiride, trifluoperazine, and zucloperithixol.
    NB: The dosing cycle for depot medication must have completed, and treatment with clozapine must have stopped at least 28 days previously, in order for a subject to be enrolled.
    8. Administration of hepatic enzyme inducers / inhibitors in the 14 days preceding enrolment into the study, or concomitant use during the study, including the following:
    · Cytochrome P450 inducers: phenytoin, carbamazepine, barbiturates, rifampin, St John’s Wort and glucocorticoids
    · Cytochrome P450 inhibitors: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nalfinavir, ritonavir, fluvoxamine and saquinavir
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to compare the efficacy of quetiapine IR, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration, by assessment of Positive and Negative Syndrome Scale (PANSS) at Day 7.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) 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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned35
    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 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
    End of Trial is defined as database lock. This is the AZ standard.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state234
    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)
    At the end of the trial, care of the subject will be transfered to their responsible psychiatrist and ongoing treatment and prescription of medication for the subject will continue according to usual clinical practice.
    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 Decision2006-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-09-19
    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
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