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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-001894-24
    Sponsor's Protocol Code Number:NKP103401
    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:2004-09-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-001894-24
    A.3Full title of the trial
    A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Comparing the Efficacy and Safety of GW597599/Paroxetine combination or Paroxetine monotherapy to Placebo in Patients with Social Anxiety Disorder (SAD)
    A.4.1Sponsor's protocol code numberNKP103401
    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 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.3.2Product code GW597599
    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.3.9.1CAS number 334476-64-1
    D.3.9.2Current sponsor codeGW597599B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 nameparoxetine
    D.3.2Product code N06A B05
    D.3.4Pharmaceutical form Capsule*
    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 INNparoxetine
    D.3.9.1CAS number 61869-08-7
    D.3.9.3Other descriptive nameparoxetine hydrochloride
    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 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
    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 placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Subjects with Social Anxiety Disorder (SAD)
    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 anxiolytic efficacy of GW597599/Paroxetine combination (15 mg and 7.5 mg, respectively/day) compared to placebo in outpatients with SAD.
    E.2.2Secondary objectives of the trial
    To evaluate the anxiolytic efficacy of Paroxetine 7.5 mg/day monotherapy compared to placebo in outpatients with SAD.
    To evaluate the safety and tolerability of GW597599/Paroxetine combination (15 mg and 7.5 mg, respectively/day) and Paroxetine 7.5mg/day monotherapy compared to placebo in outpatients with SAD.
    Pharmacokinetic/pharmacodynamic (PK/PD) link between individual GW597599 and Paroxetine plasma concentration time course and individual changes on the LSAS and CGI scores.
    To assess the agreement between the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score and the IVRS LSAS total score.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The subject has a primary diagnosis of Generalised Social Anxiety Disorder/Social Phobia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, (DSM-IV, 300.23) diagnosed using psychiatric confirmation of diagnosis in conjunction with the Mini International Neuropsychiatric Interview (MINI), Clinician Rated version 5.0.
    Note: a diagnosis of Generalised Social Anxiety Disorder will be considered to have been established if the subject reports/admits to four or more phobic situations including at least two which are interactional situations.
    2. Male and female subjects must be 18-65 years of age.
    3. Subjects must be willing to restrict alcohol intake to 3 units or less per day for males, 2 units or less per day for females. A unit is equivalent to 300 mL of beer or one measure of spirits or one glass of wine.
    4. The subject must have the ability to comprehend the key components of the consent form and must have given written informed consent to participate in the study prior to commencing any study specific procedures.
    E.4Principal exclusion criteria
    1. Subjects who score 1 or 2 on the CGI global improvement item at baseline.
    2. Subjects with a score 15 or more on the HAMD17item at screening.
    3. Subjects who meet DSM-IV criteria for any other Axis I disorder as a primary diagnosis at or within 6 months prior to the screening visit.
    4. Subjects with body dysmorphic disorder.
    5. Subjects with a history of schizophrenia, schizoaffective disorder, or a bipolar disorder.
    6. Subjects who meet DSM-IV criteria for substance abuse (alcohol or drugs) currently or within 6 months prior to screening
    7. Subjects who meet DSM-IV criteria for substance dependence (other than nicotine or caffeine) currently or within 6 months prior to screening.
    8. Subjects have any screening laboratory value outside of the Sponsor-specified ranges at the Screening Visit. Testing may be repeated once to see if the value returns to within range but any such laboratory abnormality must be resolved by the Baseline Visit.
    9. Subjects have any laboratory abnormality that in the Investigator’s judgement is considered to be clinically significant and not resolved by the Baseline Visit (even if not outside of Sponsor-specified ranges).
    10. Subjects have a positive urine test at Screening for illicit drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months. Subjects have a blood alcohol level of ≥15 mg/dL (0.015%) at the Screening Visit.
    11. Subjects with an unstable medical disorder; or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of GW597599 or paroxetine; may pose a safety concern; or interfere with the accurate assessment of safety or efficacy.
    12. Subjects with a history of myocardial infarction within one year prior to the Screening Visit.
    13. Subjects who are not euthyroid based on lab results at the Screening Visit. Subjects maintained in thyroid medication must be euthyroid for a period of at least six months prior to the Screening Visit.
    14. Subjects have any screening electrocardiographic (ECG) parameter outside of the Sponsor-specified ranges; the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the Baseline Visit.
    15. Subjects have any ECG finding that in the Investigator’s judgement is considered to be clinically significant and not resolved by the Baseline Visit.
    16. Subjects who have taken any of the following psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) must have stopped taking these drugs within the time frames specified below prior to the Baseline Visit (for a listing see the protocol). All of the above psychotropic drugs are not allowed for the duration of the study, including the two-week period preceding the mandatory 14-Day Follow-up Visit. All other (non-psychotropic) drugs metabolised via the P450 3A4 pathway must be discontinued from screening and are not allowed for the duration of the study.
    17. Subjects who are 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 preceding month for studies unrelated to SAD, or 12 months for studies related to SAD.
    18. Subjects who have received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the 6 months prior to the Screening Visit.
    19. Subjects receiving or planning to undergo regularly scheduled psychotherapy during the study (from the initial Screening Visit until the completion of the mandatory 14-Day Follow-up Visit). This is not intended to exclude supportive therapy.
    20. Subjects with a history of seizure disorders (except for febrile seizures in childhood).
    21. Subjects who have exhibited intolerance to NK1 receptor antagonists or SSRIs.
    22. Subjects who, in the investigator's judgement, pose a homicidal or serious suicidal risk, have made a suicide attempt within the 6 months preceding the Screening Visit or who have ever been homicidal.
    23. Women who have a positive serum HCG pregnancy test at Screen visit, a positive urine dipstick test at Baseline or who are lactating or planning to become pregnant within the next 18 weeks following the screen visit.
    24. Women of childbearing potential who are not able to commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are listed in the protocol.
    25. Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (e.g., illiteracy or planned vacations, planned hospitalisations during the study).
    26. Subjects who take triptan medications.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score at Week 12 LOCF. The primary comparison of interest is GW597599/Paroxetine combination versus placebo.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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) 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.8.5The 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
    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 months
    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 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 2004-09-24. 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 state56
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 204
    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 Decision2004-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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