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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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:2008-008527-14
    Sponsor's Protocol Code Number:Q8012-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-02-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-008527-14
    A.3Full title of the trial
    A Randomized, Double-Blind, Active Controlled Study Comparing the Intravenous Dose of Morphine and Oxycodone Combined in a Ratio of 1:1 Versus Morphine Alone Required to Achieve Effective Pain Control After Total Hip Replacement and the Untoward Effects of Combined Morphine and Oxycodone vs. Morphine Alone
    A.3.2Name or abbreviated title of the trial where available
    Duale Opioide Studie
    A.4.1Sponsor's protocol code numberQ8012-001
    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 SponsorUniversity of Witten/Herdecke
    B.1.3.4CountryGermany
    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 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 Yes
    D.2.1.1.1Trade name Oxygesic Injekt 10mg/1ml
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    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 nameOxygesic injekt 10mg/1 ml
    D.3.4Pharmaceutical form Injection*
    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 INNOXYCODONE HYDROCHLORIDE
    D.3.9.1CAS number 124903
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.3Concentration number10mg/ to 1ml
    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 Morphin Merck 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Pharma GmbH
    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 nameMorphin Merck 10 mg
    D.3.4Pharmaceutical form Injection*
    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.3.9.1CAS number 52266
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.3Concentration number10mg/ to 1ml
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To determine whether the intravenous coadministration of morphine and oxycodone has fewer opioid related adverse effects (AEs) than morphine alone at doses that result in effective and equi-analgesic pain relief for acute post operative pain, and to determine the doses of morphine and oxycodone co-administered versus morphine required to achieve effective pain relief.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036276
    E.1.2Term Postoperative analgesia
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the side effects with multiple dose intravenous coadministration of morphine and oxycodone vs. morphine alone at doses that result in effective relief of pain, defined as a score of 2 or less on the 11 point NPRS (Numeric Pain Rating Scale)
    E.2.2Secondary objectives of the trial
    To compare the doses of opioid used and the analgesic efficacy provided by intravenous morphine plus oxycodone versus morphine alone in all study participants, including patients who do not achieve the target NPRS score (≤ 2) for comparison of equi-analgesic effects.

    To evaluate the safety and tolerability of intravenous co administration of morphine and oxycodone compared to morphine alone following repeat administration of study medication during the post operative period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To qualify for enrollment in this study, the patient must:
    -have voluntarily provided written informed consent and HIPAA authorization prior to any study-related procedures are performed;
    -be male or female, at least 18 years of age, at the time of enrollment;
    -have undergone a primary unilateral total hip replacement performed under standardized general, spinal, or epidural anesthesia;
    -be scored I-III on the American Society of Anesthesiologists (ASA) physical status classification system;
    -have developed moderate or severe pain on a 11-point NPRS (> 4) scale within 6 hours post end of surgery (time of last stitch)on the day of surgery.
    E.4Principal exclusion criteria
    A patient will be excluded from enrollment in this study if the patient:
    -has a history of acute or severe asthma, chronic pulmonary disease, renal disease, Addison’s disease (chronic adrenal insufficiency), head injury, elevated intracranial pressure, convulsive states, congestive heart failure current cardiac arrhythmia, current transient cerebral ischemic attacks, current uncontrolled unstable co-existent systemic disease, other medical condition, laboratory abnormality, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study;
    -has allergy, hypersensitivity, or contraindications to opioids or acetaminophen;
    -has positive HIV serology or signs of HIV infection or AIDs;
    -has positive HBsAg or HCV antibody;
    -has undergone any other surgical procedure, either related or unrelated, during the same surgery session;
    -has a total hip replacement procedure time greater than 6 hours;
    -has a history of drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements;
    -has current evidence of alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment Period – Part 1
    1. The number (%) of patients in the morphine/oxycodone and morphine treatment groups who achieve the target pain score defined as mild or no pain on the 4 point Likert scale or 2 or less on the 11 point NPRS (NCA responders).
    2. The change in pain scores from baseline, as well as the percentage of patients categorized as Responders for the following time intervals: during the NCA period just prior to administration of study medication at Time 0 (Baseline) to 30 min and to 60 minutes and to the end of the NCA period (Part 1), and every 4 hours during the PCA (Part 2) period until hour 48 or time or early termination. Responders are defined as subjects with a decrease from baseline in NPRS score of at least 30%. Responder analysis will also be evaluated for decrease from baseline in NPRS score or 10%, 20%. 40%,and 50%.
    3. The amount of study medication (measured in “mg”) required by patients in each treatment group for the Part 1 and Part 2 time intervals specific in item 2, above.
    4. Patient Global Assessment of Effectiveness at approximately 8AM on the day following surgery (Day 2) and at hour 48 or at time of early termination.
    5. The amount of supplemental analgesia (measured in “mg”) required by patients in each treatment group on Day 1 (for each time interval and overall).
    6. Time to first dose of PCA medication from the end of NCA, for NCA responders in each treatment group.
    Treatment Period – Part 2
    1. SPID4H scores for the following time intervals: from the start of Part 2 on Day 1 to the end of the 48 hour evaluation period
    2. Percent Reduction Responders from the start of Part 2 on Day 1 to the 8 AM on Day 2 and from 8 AM on Day 2 to Hour 48. Responders are defined as subjects with a decrease from baseline in NPRS score of at least 30%.. Responder analysis will also be evaluated for decrease from baseline in NPRS score or 10%, 205. 40%,and 50%.
    3. The amount of study medication (measured in “mg”) required by patients in each treatment group for the following time intervals: from the start of Part 2 on to the end of the study.
    4. Patient Global Assessment of Efficacy for the following time intervals: from the start of Part 2 on Day 1 to the end of the study.
    5. The amount of supplemental analgesia (measured in “mg”) required by patients in each treatment group from the start of Part 2 to the end of the 48 hour evaluation period will also be determined.
    For the efficacy endpoints, observations will be summarized by treatment group and by analysis populations.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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.8.3 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 concerned2
    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 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
    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 months3
    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) No
    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 state40
    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)
    The patients should get routine treatment.
    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 Decision2009-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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