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    Summary
    EudraCT Number:2006-004075-36
    Sponsor's Protocol Code Number:R-01270-A016
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-004075-36
    A.3Full title of the trial
    A randomized, double blind, placebo-controlled, single-dose, parallel-group comparison of the analgesic efficacy, safety and local tolerability of intravenous Paracetamol 1% solution Bioren (test), Perfalgan® 1% (reference), and placebo in a post-surgical total hip replacement model
    A.3.2Name or abbreviated title of the trial where available
    Paracetamol in Orthopaedic pain
    A.4.1Sponsor's protocol code numberR-01270-A016
    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 SponsorBaxter R&D Europe S.C.R.L.
    B.1.3.4CountryBelgium
    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 nameParacetamol 1% Bioren
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNParacetamol
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Perfalgan 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb GmbH & Co. KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePerfalgan 10 mg/ml
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNParacetamol
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-surgical orthopedic pain after primary, cemented total hip replacement associated with moderate to severe pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054710
    E.1.2Term Postoperative hip pain
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative 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 demonstrate the therapeutic efficacy and safety of a single dose of 100 mL 1% paracetamol solution Bioren compared to placebo in terms of total morphine consumption over 6 hours after the first study drug administration.
    E.2.2Secondary objectives of the trial
    To compare the therapeutic efficacy and safety of single and repeated dose(s) of 100 mL 1% paracetamol solution Bioren to 100 mL Perfalgan®1%.

    To compare the therapeutic efficacy and safety of repeated doses of 100 mL 1% paracetamol solution Bioren to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided written informed consent prior to performing any study related procedures.

    2. Male / female subjects, 18-75 years of age inclusive.

    3. Body mass index (BMI) 18-40 inclusive.

    4. Subject is in good health as determined by the Principal Investigator on the basis of medical history and physical examination.

    5. American Society of Anesthesiologists (ASA) Grade I, Grade II or Grade III, scheduled for elective total hip replacement, using a standard approach and a cemented implant.

    6. A negative urine pregnancy test for all female subjects of childbearing potential (a female is considered to be of childbearing potential if they have not been postmenopausal for at least 24 consecutive months or if they have a uterus and at least one ovary) immediately before surgery (performed on the ward in the morning of the procedure).

    7. Subjects will be randomized and assigned medication if they rate their pain as moderate or severe assessed on a four-point verbal rating scale (VRS) within 4 hours of stopping the PCA in the morning of the first post-operative day.
    E.4Principal exclusion criteria
    1. Another acute or chronic painful physical condition (e.g.: concomitant malignant disease).

    2. The subject requires a total hip replacement due to a fracture of the hip.

    3. The use of non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, within the 12 hours preceding administration of study medication.

    4. The use of any other analgesic drugs (except morphine administration by PCA) within the 12 hours preceding administration of study medication.

    5. Specifically excluded are tricyclic antidepressants (TCAs), antihistamines, tranquilizers, hypnotics, sedatives and Cyclooxygenase-2 (COX-2) specific inhibitors.

    6. The use of any corticosteroid drugs within the 7 days preceding administration of study medication.

    7. The subject has a history of uncontrolled chronic disease, which in the opinion of the Principal Investigator would contraindicate study participation.

    8. The subject has a disease/condition that is known to be a contraindication for treatment with morphine.

    9. Inability to use or understand the visual analog scale (VAS) pain score
    and/or the Verbal Rating Score (VRS).

    10. Known hepatic disorders: Liver dysfunction defined as an elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamyl transpeptidase (GGT) 2 times above the upper limit of normal (ULN).

    11. Known renal disorders: Advanced renal dysfunction defined as an elevation of serum creatinine 2 times the ULN.

    12. Known genetic defect of glucose-6-phosphate-dehydrogenase.

    13. Psychiatric or medical conditions which would preclude safe surgery.

    14. Concomitant use of microsomial enzyme inducers (see Appendix B).

    15. Pregnant or breast feeding women.

    16. Women of childbearing potential not using adequate contraception (one method of contraception is considered to be adequate).

    17. Known sensitivity to the NSAID class of drugs, paracetamol or other analgesics.

    18. A contraindication to paracetamol.

    19. History of non-response to paracetamol.

    20. A bleeding disorder.

    21. Any history of gastrointestinal bleeding.

    22. Any laboratory abnormality, which in the opinion of the Principal Investigator would preclude study participation.

    23. History of analgesic, narcotic or alcohol dependence (substance abuse).

    24. History of participating in another clinical investigation, or taking another investigational drug within 1 month prior to surgery.

    25. Dehydration or chronic malnutrition.

    26. Confined persons and prisoners.
    E.5 End points
    E.5.1Primary end point(s)
    Total consumption of morphine over the first 6 hours following the first administration of study medication (comparison test vs. placebo).
    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 Yes
    E.6.13.1Other scope of the trial description
    Local tolerability
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-Dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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 Information not present in EudraCT
    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 regular end of the study is defined as the date the last patient completed the follow-up (via phone call if the subject has been discharged from hospital).
    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 months12
    E.8.9.1In the Member State concerned days
    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 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 state144
    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.
    Not different from the expected normal treatment of that condition.
    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 Decision2007-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-20
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