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    Summary
    EudraCT Number:2013-000938-35
    Sponsor's Protocol Code Number:1SPR11001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-000938-35
    A.3Full title of the trial
    A Single Arm, Open Label Study to compare the Pharmacokinetics, Safety, and Efficacy of SPRIX® (intranasal ketorolac tromethamine) in 12 to 17 Year-Old Patients vs. Adult Patients (18 - 64 Years) Undergoing Open Surgical Procedures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare pediatric patients ages 12-17 to adult patients ages 18-64 and see how much study drug SPRIX is in the blood, how safe the study drug SPRIX is and how well it decreases pain after surgery.
    A.4.1Sponsor's protocol code number1SPR11001
    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 SponsorLuitpold Pharmaceuticals, Inc.
    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 supportLuitpold Pharmaceuticals, Inc. Clinical Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLuitpold Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address800 Adams Avenue, Suite 100
    B.5.3.2Town/ cityNorristown, PE
    B.5.3.3Post code19403
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016106504200
    B.5.5Fax number0016106507781
    B.5.6E-mailabutcher@lpicrd.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 SPRIX®
    D.2.1.1.2Name of the Marketing Authorisation holderLuitpold Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Nasal spray
    D.3.4.1Specific paediatric formulation No
    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 INNKETOROLAC TROMETHAMINE
    D.3.9.1CAS number 74103-07-4
    D.3.9.4EV Substance CodeSUB02835MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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) 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 No
    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
    post open surgery pain (incuding but not limited to orthopedic, abdominal, thoracic, plastic/reconstructive, neurologic [spine], or urologic procedures)
    E.1.1.1Medical condition in easily understood language
    pain after open surgical procedures
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the pharmacokinetics of SPRIX administered postoperatively to pediatric patients (ages 12-17) relative to adults (ages 18 – 64) undergoing open surgical procedures.
    E.2.2Secondary objectives of the trial
    To assess the safety and efficacy of postoperative administration of SPRIX in pediatric patients (ages 12-17) undergoing open surgical procedures.
    To assess whether a dose of 31.5 mg (2 sprays) of SPRIX is safe and effective in adult subjects weighing 30 to 50 kg and yields plasma levels similar to that of subjects weighing more than 50 kg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient age 12-64 years.
    2. Undergoing an open surgical procedure expected to result in at least moderate pain based (at least 40 on 0-100 mm VAS).
    3. Body mass index (BMI) ≤ 95th
    4. Surgical procedures that would allow the subject to likely remain in hospital until the morning of post-operative day 3 (to complete PK sample collection) percentile for age;
    5. Willing and able to complete the study procedures and pain scales and to communicate meaningfully with the study personnel (with parental assistance if pediatric);
    6. In generally good health and capable of undergoing surgery;
    7. Females at risk of pregnancy were to use an acceptable form of birth control and have a negative serum or urine pregnancy test.
    8. Willing to refrain from use of non-study analgesics for the duration of the study, from the day of surgery up to post-operative day 4
    9. Assents to participation (if pediatric) and his/her parent or guardian is willing and able to sign the informed consent approved by the IRB. Consents to participation and willing and able to sign the informed consent approved by the IRB if adult.
    E.4Principal exclusion criteria
    1. Surgical procedure performed exclusively by laparoscopy;
    2. Known allergy or sensitivity to ketorolac, ethylene diamine tetraacetic acid (EDTA),or any nonsteroidal anti-inflammatory drug (NSAID);
    3. Prior nasal-septal injury or surgery;
    4. History of peptic ulcer, gastro-esophageal reflux, or gastrointestinal bleeding;
    5. History of advanced renal impairment or a risk for renal failure due to volume depletion;
    6. Clinically significant (in the Investigator’s opinion) laboratory test value outside the normal range;
    7. Use of either (a) oxycodone at a dose of 30 mg/day or more or (b) an equivalent dose of another opioid analgesic for a total of more than half of the days during the preceding month;
    8. The patient requires regular use (daily use in at least 25 days per month) in the 3 months prior to surgery of NSAIDs, COX2 inhibitors, tramadol, or acetaminophen at daily dose of more than 2 g for the management of pain;
    9. Contraindication to the use of morphine, general anesthetics, bupivacaine, ropivacaine, lidocaine, other local anesthetics, muscle relaxants, hydrocodone, ondansetron, or acetaminophen (e.g., significant history of allergic reactions or intolerance to these or related substances);
    10. Known bleeding diathesis or other disorder or current use of agents affecting coagulation. Deep venous thrombosis prophylaxis of the surgeon’s choice is permitted postoperatively;
    11. Current use of CNS active drugs such as benzodiazepines, tricyclic antidepressants, or SSRIs for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of lorazepam and other sleep medications, except those containing analgesic properties, are permitted;
    12. Current diabetes mellitus and HbA1C > 9.5 or a history of prolonged uncontrolled diabetes;
    13. Use of an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days;
    14. Any medical condition that in the investigator’s opinion could adversely impact the patient’s participation or safety, conduct of the study, or interfere with the pain assessments, including active infection;
    15. History of drug, prescription medicine, or alcohol abuse that would interfere with the subject’s safety or the assessments of efficacy in this trial, in the judgment of the investigator;
    16. History of nasal mucosal damage or active seasonal allergies, nasal congestion or upper respiratory tract infection sufficient to interfere with intranasal drug delivery;
    17. Administration of an investigational product within 3 months prior to the first dose of study drug, or scheduled to receive an investigational product, while participating in the study.
    18. Use of Toradol (ketorolac tromethamine) in any formulation within the past 30 days prior to study entry and throughout study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Key endpoints in this trial are pharmacokinetics and safety.

    The measures of safety to be used in this study are routine clinical and laboratory procedures, with the addition of pulse oximetry for the measurement of continuous oxygen saturation during the period of parenteral opioid use and nasal examinations to evaluate local toxicity.

    Pharmacokinetics (PK): Blood samples will be obtained for PK analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: at screening and at the final visit before discharge.

    Pharmacokinetics (PK): Blood samples will be collected for PK assessment pre-dose and at 0.25, 0.5, 0.75, 1, 2, and 4 hrs after the dose as well as at 6 hrs (prior to administration of the subsequent dose). Blood samples for PK will be collected prior to each subsequent dose of study drug (i.e., at 12, 18, 24 hr, etc). On the morning of post operative day 2 (i.e., Day 2 when the Day of surgery is designated Day 0) until the morning of post-op day 2 a blood sample
    for PK assessment will be obtained prior to dosing and then a single dose of study drug for that day will be administered. Blood samples for PK assessment will then be collected at 1, 2, 4, 6, 8, 12, and 24 hrs after receiving this single dose.
    E.5.2Secondary end point(s)
    The efficacy measure to be used in this study is summed pain intensity difference (SPID). Pain intensity will be assessed via a 0-100 mm VAS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will be assessed pre-dose (1st dose of SPRIX) as well as 30 and 60 minutes, and 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose then following the 48-hour dose, immediately before each subsequent dose up to 5 days in total.
    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 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) 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned7
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    Last follow-up call to last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days12
    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: 36
    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: 36
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    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 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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 59
    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 will receive standart medical care after termination of the study.
    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 Decision2013-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-03
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