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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2006-005403-34
    Sponsor's Protocol Code Number:CP045/06/FCNS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-02-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-005403-34
    A.3Full title of the trial
    An open-label study investigating long-term safety and tolearability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy
    A.4.1Sponsor's protocol code numberCP045/06/FCNS
    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 SponsorArchimedes Development Ltd
    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 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 nameNasalfent
    D.3.4Pharmaceutical form Nasal spray*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENTANYL CITRATE
    D.3.9.1CAS number 990738
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENTANYL CITRATE
    D.3.9.1CAS number 990738
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.3.11.13.1Other medicinal product typeopioid analgesic
    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
    The treatment of Breakthrough Cancer Pain (BTCP) in subjects taking regular opioid therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10058019
    E.1.2Term Cancer pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the long-term safety, tolerability, and acceptability of Nasalfent in the treatment of BTCP.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria Subjects will be included in the study if they meet all of the following criteria: 1. EITHER The subject was previously enrolled in Studies CP043/06/FCNS or CP044/06/FCNS and: a. Successfully completed the study (including the return of any remaining drug supplies and successful completion of the subject diaries). b. Continues to experience episodes of breakthrough pain that were adequately controlled with a designated dose of Nasalfent in Studies CP043/06/FCNS or CP044/06/FCNS. c. The subject’s medical condition is such that the subject continues to meet the other inclusion/exclusion criteria listed below. OR The subject has not participated in Studies CP043/06/FCNS or CP044/06/FCNS and wishes to participate in this study (CP045/06/FCNS). 2. Subjects who are able and willing to provide written informed consent. 3. Male or female subjects, 18 years of age and older. 4. If female, and of childbearing potential (not surgically sterile or ≤1 year after the onset of amenorrhea due to menopause), must (a) have a negative serum pregnancy test, (b) not be lactating, and (c) agree to practice a reliable form of contraception or abstinence during the study. 5. Subjects who have a histologically documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain. 6. Subjects who are taking at least 60 mg oral morphine or equivalent for at least 1 week for cancer-related pain as regular, 24-hour medication for their underlying persistent cancer pain. 7. Subjects who are experiencing, on average, but not necessarily every day, 1 to 4 episodes of BTCP per day that are adequately controlled with a stable dose of standard rescue medication, typically a fast-acting opioid, of which the subject should have an adequate supply throughout the study. Breakthrough pain is defined as a transitory flare of moderate to severe pain (on a 4 point scale from 0 to 3 [none, mild, moderate, severe] as defined by the Breakthrough Pain Questionnaire in Section 15.2) that occurs on a background of persistent pain controlled to moderate intensity or less by the opioid regimen. If the subject has more than 1 type of breakthrough pain, or has breakthrough pain in more than 1 location, only 1 of the pains will be identified as a “target” breakthrough pain. 8. Subjects who, in the opinion of the investigator, are willing and able (personally or with the help of a caregiver) to a. Evaluate and record pain intensity and pain relief. b. Assess medication performance at specific times after dosing. c. Record AEs. d. Record each instance of the use of study drug and standard rescue medication in a subject diary for the duration of the study. 9. Subjects with an Eastern Cooperative Oncology Group (ECOG) score of ≤2 and a life expectancy which, in the opinion of the investigator, will allow them to participate for the duration of the study.
    E.4Principal exclusion criteria
    Exclusion Criteria Subjects may be excluded from participating in the study if they meet any of the following criteria: 1. Subjects with an opioid or fentanyl intolerance. 2. Subjects with uncontrolled or rapidly escalating pain. 3. Subjects using intrathecal or epidural opioids. 4. Subjects whose condition is unstable or rapidly deteriorating, such that they are (in the opinion of the investigator) unlikely to be able to make an effective contribution to the study. 5. Subjects with sleep apnea or active brain metastases with increased intracranial pressures. 6. Subjects with any respiratory or cardiac condition that, in the opinion of the investigator, may be worsened by opioids. 7. Subjects with any other medical condition that, in the judgment of the investigator, would confound the objectives of the study. 8. Subjects with a recent history of alcohol or substance abuse that would compromise data collection. 9. Subjects with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection. 10. Subjects with clinically significant renal and hepatic dysfunction test results at Screening outside the following limits: a. Serum creatinine must be ≤2.0 mg/dL, or creatinine clearance calculated by Cockcroft-Gault formula must be ≥50 mL/min. b. Serum total bilirubin must be ≤2.0 mg/dL. c. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase must be ≤3 times the upper limit of normal (≤5 times the upper limit of normal if due to liver metastases). 11. Subjects taking any medication likely to affect the physiology of the nasal mucosa. 12. Any abnormal nasal physiology and/or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished. 13. Subjects with known intolerance to nasal sprays and/or pharmaceutical materials found in the investigational products. 14. Subjects taking monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit or with an anticipated need for MAOIs during the study. 15. Subjects with uncontrolled infection. 16. Subjects who have received treatment with an investigational drug (other than those in Studies CP043/06/FCNS and CP044/06/FCNS) within 4 weeks of the screening visit. 17. Subjects whose primary source of breakthrough pain is not cancer related.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events. Objective nasal examination. Subjective nasal assessment. Withdrawal due to AEs. Physical examination, including vital signs. Laboratory assessments. Subject acceptability assessments.
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 500
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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