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    Summary
    EudraCT Number:2014-002405-37
    Sponsor's Protocol Code Number:PD2013-002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-11-11
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-002405-37
    A.3Full title of the trial
    An open label evaluation of the safety and clinical utility of the active, separated system with enhanced controller (SSEC) fentanyl 40 mcg for the management of acute postoperative pain in pediatric patients 12 to less than 18 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and usefulness of fentanyl 40 mcg in the management of pain for up to 72 hours following surgery in patients aged 12 to less than 18 years.
    A.4.1Sponsor's protocol code numberPD2013-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02395653
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/111/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIncline Therapeutics Inc, a wholly owned subsidiary of The Medicines Company
    B.1.3.4CountryUnited States
    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 supportIncline Therapeutics Inc,a wholly owned subsidiary of The Medicines Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncline Therapeutics Inc, a wholly owned subsidiary of The Medicines Company
    B.5.2Functional name of contact pointGlobal Health Science Center
    B.5.3 Address:
    B.5.3.1Street Address900 Saginaw Drive, Suite 200
    B.5.3.2Town/ cityRedwood City, California
    B.5.3.3Post code94063
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650 241-6800
    B.5.6E-mailmedical.information@themedco.com
    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 IONSYS 40 micrograms per dose transdermal system
    D.2.1.1.2Name of the Marketing Authorisation holderIncline Therapeutics Europe Ltd (a wholly owned subsidiary of The Medicines Company)
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIONSYS 40 micrograms per dose transdermal system
    D.3.4Pharmaceutical form Transdermal system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl HCl
    D.3.9.3Other descriptive nameFENTANYL
    D.3.9.4EV Substance CodeSUB07597MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain in pediatric inpatients
    E.1.1.1Medical condition in easily understood language
    Postoperative pain in hospitalised children
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10036286
    E.1.2Term Post-operative pain
    E.1.2System Organ Class 100000004863
    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 safety and clinical utility of the active, separated system with enhanced controller (SSEC) fentanyl 40 mcg for the management of acute, postoperative pain in pediatric patients, 12 to less than 18 years of age.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients whose parent(s) or guardian(s) have/has signed and dated an informed consent form for the patient to participate in the study, or patients who have provided written assent to participate in the study.
    2. Male or female inpatients, age 12 to < 18 years of age inclusive on the day of surgery
    3. Patients capable of understanding and cooperating with the requirements of the study, including being able to report their pain intensity using the 11-point NRS and operate the SSEC.
    4. American Society of Anesthesiologists (ASA) physical status I, II or III.
    5. Body weight of at least 40.0 kg.
    6. Postoperative patients who have undergone general or regional anaesthesia for abdominal, pelvic/genitourinary, orthopaedic, or thoracic surgery.
    7. Postoperative patients who have been observed during recovery and are expected to remain hospitalized and have pain requiring parenteral opioids (i.e., IV PCA) for the next 24 hours or longer.
    8. Patients who are awake and breathing spontaneously with a respiratory rate of 14 to 18 breaths per minute, SpO2 ≥93% (with or without supplemental oxygen), and able to answer questions and follow commands.
    9. Patients who have been observed during recovery, who are awake, able to answer questions and follow commands, and who have been comfortable for at least 30 minutes with a pain intensity score ≤ 4 (numeric rating scale 0–10), with or without titration to comfort with IV opioids.
    E.4Principal exclusion criteria
    1. Patients who have undergone any surgery on the airway, head, or neck.
    2. Patients who received an extended-release opioid within 48 hours prior to Hour 0 or who are expected to have postoperative analgesia supplied by a continuous regional technique or patient-controlled epidural analgesia.
    3. Patients with a history of allergy or hypersensitivity to fentanyl, skin adhesives, and/or cetylpyridinium chloride.
    4. Patients who are expected to require intensive care or will likely require additional surgical procedures within 36 hours.
    5. Patients who received intra-operative and/or postoperative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil, or alfentanil. Exception: If there are no medical contraindications, meperidine (pethidine) up to 0.5 mg/kg IV is permitted during recovery for shivering.
    6. Patients who require airway support (nasal or oropharyngeal airway intubation, or laryngeal mask airway [LMA]) at the time of final baseline assessments (i.e., at the time of IONSYS application [Hour 0]).
    7. Patients who are known or suspected to be opioid tolerant, have a history of opioid dependence within 3 months before the start of the study, or who are known to have used illicit drugs or alcohol within 14 days of the start of the study.
    8. Patients with active generalized skin disorders or active local skin disease that precludes SSEC application to the chest or upper arm.
    9. Patients with any coexisting major medical conditions that are likely to interfere with study procedures including, but not limited to, psychiatric conditions, chronic depression, suicidal ideation, autism.
    10. Positive pregnancy test for any female.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    • Changes in vital signs from baseline, including clinically relevant respiratory depression
    • Changes in skin irritation assessments from baseline
    • Incidence of adverse events (AEs) and serious adverse events (SAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days
    E.5.2Secondary end point(s)
    Clinical Utility Endpoints :
    • Evaluation of the patient's ability to use SSEC
    • Assessment of adherence of the SSEC system

    Pharmacokinetic Endpoint:
    • Serum fentanyl concentration at each time point will be assessed

    Other Endpoints:
    • Pain intensity scores
    • Pain intensity ratings
    • Patient, parent/guardian, and investigator global assessments
    • Opioid rescue medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints up to 72 hours
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Clinical utility
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    Patients with ongoing adverse events at study termination will be followed until all significant changes have been resolved or the patient becomes medically stable.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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