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    Summary
    EudraCT Number:2013-005327-16
    Sponsor's Protocol Code Number:
    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:2014-07-09
    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 number2013-005327-16
    A.3Full title of the trial
    A Randomized Open Label Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function after Colorectal Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is Targinact able to reduce gut side-effects of painkillers given after bowel surgery?
    A.3.2Name or abbreviated title of the trial where available
    Targinact after Colorectal Surgery (TACS)
    A.4.1Sponsor's protocol code number
    A.5.4Other Identifiers
    Name:Clintrials.gov NumberNumber:NCT02109640
    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 SponsorThe University of Edinburgh
    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 supportNapp Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWestern General Hospital, Edinburgh
    B.5.2Functional name of contact pointHugh Paterson
    B.5.3 Address:
    B.5.3.1Street AddressCrewe Road
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH4 2XU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07780957402
    B.5.6E-mailHugh.Paterson@nhslothian.scot.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4Country
    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 supportNapp Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWestern General Hospital, Edinburgh
    B.5.2Functional name of contact pointHugh Paterson
    B.5.3 Address:
    B.5.3.1Street AddressCrewe Road
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH4 2XU
    B.5.4Telephone number07780957402
    B.5.6E-mailHugh.Paterson@nhslothian.scot.nhs.uk
    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 Targinact
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    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.3.1Product nameTarginact
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxycodone hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone hydrochloride
    D.3.9.1CAS number 357-08-4
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative pain
    E.1.1.1Medical condition in easily understood language
    Post-operative pain
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study will be to compare Targinact (prolonged release naloxone + oxycodone) with current standard treatment (oxycodone alone) in post-operative return of normal gut function after elective colorectal resectional surgery.
    E.2.2Secondary objectives of the trial
    Since this is a pilot trial of a complex intervention, the study will gather data on aspects of study design, such as protocol compliance and treatment effect size, and record comprehensive data on return of gastrointestinal function with a view to deriving a composite end-point definition for the design of subsequent larger trials in colorectal surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients scheduled for elective laparoscopic hemicolectomy at the Colorectal Surgery Unit, Western General Hospital, Edinburgh.
    E.4Principal exclusion criteria
    Pregnancy
    Patients lacking capacity to give informed consent.
    Severe liver dysfunction (Child’s A or greater)
    Patients participating in another therapeutic clinical trial
    Contraindication to oxycodone, naloxone or Targinact
    Pre-existing dependence on opioid analgesia (current medications will be checked prior to discussing consent)
    Pre-existing use of opioid analgesia for chronic pain (current medications will be checked prior to discussing consent)
    Patients with rectal cancer
    Plan to form any stoma during procedure
    E.5 End points
    E.5.1Primary end point(s)
    25% reduction in rate of gut dysfunction (defined as nausea, vomiting, intolerance of oral intake or constipation sufficient to delay discharge) on programmed day of discharge (3rd postoperative day).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3rd postoperative day
    E.5.2Secondary end point(s)
    Equivalence of pain control
    Measured by:
    • Total quantity of Morphine Rescue PCA used over standard analgesia protocol (see perioperative management protocol)
    • Total dose of oral Oxycodone or Targinact until discontinued by the patient/discharged from hospital
    • Pain scores will be recorded using the OBAS multi-dimensional quality assessment tool. This assesses pain at rest, overall satisfaction with pain relief in previous 24 hours and side effects of analgesia (sweating, itching, vomiting, dizziness).
    • Activity monitors will be used to measure mobilisation and inform the assessment of dynamic pain relief


    Return of gut function
    Multiple measures will be employed to record both presence of good function and absence of dysfunction
    • Time to first flatus
    • Time to first bowel movement
    • Time from surgery to cessation of iv fluids (excluding 10ml/hr used to maintain patency of PCA)
    • Total dose of rescue antiemetic (protocol ondansetron not included)
    • Reinstitution of iv fluids due to inadequate oral intake (Y/N)
    • Measurement of oral nutritional intake:
    Preoperative intake will be recorded by means of a recall diary. Postoperative oral intake will be recorded by the patient using a food diary for 7 days from the date of surgery, supplemented by digital photography to calculate the protein/calorie content of what was offered at mealtimes and what was actually consumed. Energy intake will then be estimated using CompEat Pro® forWindows® (Nutrition Systems, Banbury, UK). Time to attain and maintain 80% of normal solid food intake and the percentage Recommended Nutritional Intake (RNI) achieved on the first 3 days after surgery for each subject will be used in comparisons between study groups.
    • Validated nausea and vomiting score (Miles and Wengritzky)
    • Presence of abdominal distension (Y/N)
    • 13C Stable Isotope Gastric Empting Breath Test to measure gastric motility on the second postoperative morning[10]. The technique has been previously used in the Edinburgh School of Surgery and validated as a reproducible and accurate measurement of upper GI motility.

    Additional data to be recorded:
    • Patient demographics, co morbidity, regular medications
    • Pre op bowel function questionnaire
    • PONV prediction data (Apfel score)
    • Day 3 achievement of discharge criteria (pain controlled by oral analgesia, tolerating adequate oral diet and fluids, independently mobile and nausea controlled by oral medication) Y/N
    • 30-day/Inpatient mortality
    • Duration of hospital admission
    • Complications (recorded by organ system and severity as assessed by Clavien/Dindo scale)
    • Unscheduled readmissions to hospital within 30 days of discharge
    • Protocol compliance analysis
    • Patient-reported outcome questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily for 7 post-operative days
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    The end of the trial will be at the last 30 day follow up of the last participant, unless AEs require ongoing follow-up to ensure resolution in which case end of trial will be extended to this point.
    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 months1
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 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 state50
    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)
    Not applicable. Most patients will discontinue opioid analgesia within 7 days of discharge from hospital as postoperative pain resolves.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-16
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