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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-000586-26
    Sponsor's Protocol Code Number:TIME3UK
    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:2009-01-15
    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 number2008-000586-26
    A.3Full title of the trial
    Adjuvant Urokinase in the Treatment of Malignant Pleural Effusion: The Third Therapeutic Intervention in Maligant Effusion Trial (TIME3-UK). A Randomised Controlled Trial to evaluate whether use of intrapleural Urokinase aids the drainage of multi-septated pleural effusion compared to placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at using the drug urokinase to help drain fluid from around the lung (known as a malignant pleural effusion) which is caused by cancer.
    A.3.2Name or abbreviated title of the trial where available
    TIME3-UK
    A.4.1Sponsor's protocol code numberTIME3UK
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12852177
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Syner-KINASE
    D.2.1.1.2Name of the Marketing Authorisation holderSyner-Medica 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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntrapleural use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.13.1Other medicinal product typeHighly purified form of naturally occurring human urokinase extracted from urine.
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntrapleural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with malignant pleural effusions
    E.1.1.1Medical condition in easily understood language
    A cancer induced collection of fluid between the lung and the chest wall (malignant pleural effusion).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10026673
    E.1.2Term Malignant pleural effusion
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Mean daily breathlessness score over 28 days following randomisation (quantified by visual analogue scale (VAS) scores)

    2. Time to pleurodesis failure (proportion requiring further pleural fluid drainage with deaths and loss to follow up censored, log rank test). Pleurodesis failure is defined as: either another ipsilateral pleural drainage procedure to control breathlessness or the patient has symptomatic pleural fluid recurrence but another ipsilateral pleural drainage procedure is not performed due to patient refusal, futility or other medical reason e.g. warfarinisation, poor performance status.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A clinically confident diagnosis of pleural malignancy defined as;
    a. histocytologically proven pleural malignancy or
    b. Otherwise unexplained exudative pleural effusion in the context of clinically proven cancer elsewhere
    c. Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof
    2. A significant multi-loculated or multi-septated pleural effusion defined as EITHER:
    a) A chest radiograph showing >15% hemithorax area occupied by effusion OR
    b) Septated effusion on thoracic ultrasound with a basal parietal to visceral depth of >2cm
    3. Malignant pleural effusion requiring drainage and pleurodesis for symptom control.
    4. Written informed consent
    E.4Principal exclusion criteria
    1. Age < 18 years
    2. Expected survival <28 days
    3. Previous pneumonectomy on the side of the effusion
    4. Positive ipsilateral pleural fluid gram stain or bacterial culture in the previous month.
    5. Previously received intra-pleural fibrinolytic agents into this effusion
    6. Known sensitivity to urokinase
    7. Coincidental stroke, major haemorrhage or major trauma
    8. Major surgery in the previous 5 days
    9. Chylothorax
    10. Known underlying trapped lung of sufficient severity that pleurodesis is futile
    11. Patients who are pregnant or lactating
    12. Irreversible bleeding diathesis or platelet count <100 x 109
    13. Irreversible visual impairment
    14. Inability to give informed consent or comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean daily breathlessness score over 28 days following administration (quantified by visual analogue scale (VAS) scores)
    2. Time to pleurodesis failure (proportion requiring further pleural fluid drainage with deaths and loss to follow up censored, log rank test). Pleurodesis failure is defined as: either another ipsilateral pleural drainage procedure to control breathlessness
    or the patient has symptomatic pleural fluid recurrence but another ipsilateral pleural drainage procedure is not performed due to patient refusal, futility or other medical reason e.g. warfarinisation, poor performance status.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 28 days
    2.1 year/death
    E.5.2Secondary end point(s)
    1. Radiographic improvement in the area of the pleural effusion (measured as the difference in the proportion of the ipsilateral hemithorax occupied by the pleural effusion opacity on chest radiograph) on day two (the day of pleurodesis).
    2. Total volume of pleural fluid drained.
    3. Self reported health status (‘quality of life’), quantified from standard questionnaire at each trial assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30).
    4. Health care costs (from health care utilisation and cost utility analysis from EQ5D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. day 2
    2. Until drain removal/day 7
    3. 28 days, 3, 6, 12 months
    4. 1 year
    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 No
    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 No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    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
    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.1.2.1Number of subjects for this age range: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    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 2009-01-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state126
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 126
    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)
    The patients will be transferred to normal care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation National Institute of Helath Research
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-26
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