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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2005-002544-25
    Sponsor's Protocol Code Number:CL_700_002_PRO-AME3
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-20
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2005-002544-25
    A.3Full title of the trial
    A Multicentre, Multinational, Open-Label Trial (including Double-Blind, Placebo-Controlled Cross-Over Extension Part) to Evaluate the Time to Significant Pain Relief with Fentanyl TAIFUN® in the Treatment of Breakthrough Pain in Patients with Cancer on Maintenance Opioid Therapy for Persistent Pain.
    A.3.2Name or abbreviated title of the trial where available
    FIND 2: Fentanyl Inhalation in Neoplastic Disease
    A.4.1Sponsor's protocol code numberCL_700_002_PRO-AME3
    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 SponsorLAB Pharma Ltd
    B.1.3.4CountryFinland
    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 No
    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 nameFentanyl TAIFUN 100 µg/dose DPI
    D.3.2Product code F8101 (previous DE_MF_F8001)
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl Citrate
    D.3.9.1CAS number 990-73-8
    D.3.9.2Current sponsor codeF90016
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to µg/dose
    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 Yes
    D.3.11.13.1Other medicinal product typeAnalgesic
    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 No
    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 nameFentanyl TAIFUN 200 µg/dose DPI
    D.3.2Product code F8116 (previous DE_MF_158552)
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl Citrate
    D.3.9.1CAS number 990-73-8
    D.3.9.2Current sponsor codeF90016
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 to µg/dose
    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 Yes
    D.3.11.13.1Other medicinal product typeAnalgesic
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with cancer having episodes of breakthrough pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level canc
    E.1.2Classification code 10058019
    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 time to significant pain relief with Fentanyl TAIFUN® for patients with successful titration.
    E.2.2Secondary objectives of the trial
    1. To evaluate the proportion of subjects reaching successful titration.
    2. To evaluate the time to effective titration.
    3. To evaluate the dose of effective titration.
    4. To evaluate the time to subjectively significant pain relief as indicated by the patient with Fentanyl TAIFUN®.
    5. To evaluate the degree of pain relief with Fentanyl TAIFUN®.
    6. To evaluate the proportion of episodes requiring rescue medication after titration
    7. To evaluate the Global Performance of Fentanyl TAIFUN®.
    8. To monitor the functionality and the impact of pain on patient’s life with the Brief Pain Inventory (BPI, short form) with Fentanyl TAIFUN®.
    9. To evaluate the safety of Fentanyl TAIFUN®.

    Objective of the cross-over extension period:
    The primary and secondary objectives in the cross-over extension period are to compare Fentanyl TAIFUN with placebo in all applicable parameters mentioned above.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmed diagnosis of cancer
    2. Age 18 years or more
    3. Using a fixed dose of around-the-clock opioid or a combination of opioids for pain relief; either morphine 60-600mg/day, oxycodone 60-600 mg/day, methadone 15-200mg/day, transdermal fentanyl 25-300g /hr or 12-120 mg/day hydromorphone, which has been stable for at least 5 days prior to the start of titration visit
    4. Experiencing at least 1 episode of target breakthrough pain per day, which is responsive to short-acting opioid therapy
    5. Written informed consent has been obtained
    E.4Principal exclusion criteria
    1. Uncontrolled or rapidly increasing pain
    2. Uncontrolled or rapidly increasing background pain
    3. Intracranial tumours or cerebral metastases
    4. Asthma
    5. Inadequate lung function, as defined by PEFR <60% of age-adjusted normal, or any other valid method judged by the investigator appropriate
    6. Radiotherapy to the thorax within 30 days of the start of titration visit
    7. Chemotherapy with a drug not used before in this patient within 30 days of the registration visit
    8. Planned surgery during the study period
    9. Known allergy or hypersensitivity to any of the drugs under investigation or their components
    10. Any known contraindications to any of the drugs under investigation
    11. Alcohol or drug abuse
    12. Participation in any clinical study within 1 month of the start of titration visit, with the only exception of the study FIND (EUDRACT No. 2004-001620-21)
    13. Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the subject to complete the assessments
    14. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study or safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of background opioidi therapy).
    15. Pre-menopausal women (last menstruation 1 year prior to the screening visit) who:
    a. are not surgically sterile and/or
    b. have a positive pregnancy test at the randomisation visit and/or
    c. are of childbearing potential and are not practicing an acceptable means of birth control or do not plan to continue using this method throughout the study and/or
    d. are nursing
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable as given below will be measured for 5 episodes of breakthrough pain after successful titration. Each subject will be monitored for 5 episodes of “target” breakthrough pain. In addition, 6 additional episodes of “target” breakthrough pain will be monitored in the extension part of the study, for those subjects who have responded to the Fentanyl TAIFUN® treatment. Although, according to the prevailing approach in the clinical literature, each episode of breakthrough pain may be considered as independent,1, 9-11 in this study the primary variable will be derived from five episodes of target breakthrough pain occurring after titration, with the individual data of the five episodes used as an internal validity control as indicated in the statistical section (Analysis of efficacy).
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    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
    E.8.9.2In all countries concerned by the trial years1
    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) Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 62
    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 Decision2006-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-08
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