Clinical Trial Page

Summary
EudraCT Number:2004-005122-45
Sponsor's Protocol Code Number:D1441L00032
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-10-04
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
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2004-005122-45
A.3Full title of the trial
RACE : Rapid Dose Escalation of Quetiapine versus Conventional Escalation in the Treatment of Patients with Acute Schizophrenia – a Multicentre, Double-blind, Parallel group, Randomized Study
A.3.2Name or abbreviated title of the trial where available
RACE
A.4.1Sponsor's protocol code numberD1441L00032
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 GmbH
B.1.3.4CountryGermany
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.2.1.1.1Trade name Seroquel 25mg Filmtabletten
D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
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 25mg Filmtabletten
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.3.8INN - Proposed INNQuetiapine fumarate
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number25
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 2
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.2.1.1.1Trade name Seroquel 100 mg Filmtabletten
D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
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 100 mg Filmtabletten
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.3.8INN - Proposed INNQuetiapine fumarate
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 3
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.2.1.1.1Trade name Seroquel 200 mg Filmtabletten
D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
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 200 mg Filmtabletten
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.3.8INN - Proposed INNQuetiapine fumarate
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 4
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.2.1.1.1Trade name Seroquel 300 mg Filmtabletten
D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
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 300 mg Filmtabletten
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.3.8INN - Proposed INNQuetiapine fumarate
D.3.10 Strength
D.3.10.1Concentration unit mg/g milligram(s)/gram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number300
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
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
D.8 Placebo: 3
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
Patients hospitalised with a DSM-IV diagnosis of schizophrenia showing acute agitation and psychosis
MedDRA Classification
E.1.3Condition being studied is a rare disease Information not present in EudraCT
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective for the study is to evaluate the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme (300 mg on day 1, 600 mg on day 2 and 800 mg on day 3) compared to the current approved label titration (50 mg on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, 400 mg on day 5, 600 mg on day 6 and 800 mg on day 7). The safety profile of both titration schemes will be measured with the proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment.
E.2.2Secondary objectives of the trial
1. To evaluate if the initiation with 300 mg on day 1 is safe and well tolerated in the treatment of severely ill acute schizophrenic patients.
2. To evaluate if increasing the dosing up to 800mg on day 3 is safe and has a similar tolerability to the current label in the treatment of severely ill acute schizophrenic patients.
3. To evaluate if dosing with 800 mg from day 3 to day 7 is safe and has a similar tolerability to the current label in the treatment of severely ill acute schizophrenic patients.
4. To evaluate if there is a comparable safety and tolerability during the 12 days of treatment.
5. To evaluate if there is a comparable safety/tolerability profile between both titration schemes on EPS, measured by SAS and BARS.
6. To evaluate if the faster titration will provide a faster onset of efficacy measured by PANSS-EC, CGI.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
For inclusion in the study subjects must fulfil all of the following criteria:
1. Provision of written informed consent prior to enrolment.
2. Men and women age >18 to <65 years
3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following:
Schizophrenia DSM-IV
catatonic 295.20
disorganised 295.10
paranoid 295.30
undifferentiated 295.90
4. CGI-S score >4
5. PANSS score of >90 at enrolment visit as well as a score of at least 14 on the PANSS-EC, with a score of at least 4 on at least one of 5 items at both enrolment and randomization visits.
6. Female patients of childbearing potential must have a negative serum pregnancy test enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
7. Be able to understand and comply with the requirements of the study, as judged by the investigator.
8. Patient must be hospitalised during the study.
E.4Principal exclusion criteria
Any of the following is regarded as a criterion for exclusion from the study:
1. Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I disorder not in full remission, concomitant organic mental disorder or mental retardation.
2. Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence.
3. Risk of transmitting HIV or hepatitis B, via blood or other body fluids (as judged by the investigator).
4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
5. Female patients who are pregnant, lactating or at risk of pregnancy.
6. Patients with a history of non-compliance as judged by the investigator.
7. Evidence of clinically relevant disease [...] or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
8. Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the investigator.
9. ECG considered to show clinically significant abnormality at enrolment.
10. A TSH concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism.
11. Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomization day 1.
12. Use of antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic, or other psychoactive drugs within 48 hours before randomization and throughout the randomized period (except medications specified in the protocol)
13. Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 2 weeks prior randomization [...]
E.5 End points
E.5.1Primary end point(s)
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
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 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 Yes
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Tolerability
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 Yes
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 No
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
Database lock, which defines end of the study is anticipated in December 2005.
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 months7
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Information not present in EudraCT
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) Information not present in EudraCT
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 2005-10-04. 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.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)
After the subjects have completed or discontinued the study they will be treated according to local medical practise
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 Decision2005-04-04
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-05-18
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-09-13

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