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    Summary
    EudraCT Number:2014-004718-27
    Sponsor's Protocol Code Number:INRETRAM3/2014
    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:2016-12-01
    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 number2014-004718-27
    A.3Full title of the trial
    A randomised, multicenter, single-blinded, parallel-group study to assess efficacy, safety and tolerability of the combination of Immediate Release (IR) tramadol with micronized magnesium lactate as functional excipient in management of chronic pain in subjects with osteoarthritis of the hip or/and knee.
    Randomizowane, wieloośrodkowe, pojedynczo zaślepione, równoległe badanie kliniczne oceniające skuteczność, bezpieczeństwo stosowania i tolerancję leku o ustalonej dawce tramadolu i mikronizowanego mleczanu magnezu w postaci tabletek
    o natychmiastowym uwalnianiu w leczeniu bólu przewlekłego u pacjentów z chorobą zwyrodnieniową stawów biodrowych lub kolanowych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing the Effectiveness and Safety of Tramadol and micronized magnesium lactate as functional excipient to Tramadol alone for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA).
    Badanie porównujące skuteczność i bezpieczeństwo stosowania tramadolu
    i mikronizowanego mleczanu magnezu jako funkcjonalnej substancji pomocniczej oraz samodzielnie podawanego tramadolu w leczeniu umiarkowanego do ciężkiego bólu spowodowanego chorobą zwyrodnieniową stawów (OA).
    A.4.1Sponsor's protocol code numberINRETRAM3/2014
    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 SponsorMedical Unviersity of Warsaw
    B.1.3.4CountryPoland
    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 supportThe National Centre for Research and Development
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Unviersity of Warsaw
    B.5.2Functional name of contact pointDepartment of Pharmacodynamics
    B.5.3 Address:
    B.5.3.1Street Address1B Banacha Street
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-097
    B.5.3.4CountryPoland
    B.5.4Telephone number+4822116 61 26
    B.5.5Fax number+4822116 62 03
    B.5.6E-mailfarmakodynamika@wum.edu.pl
    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.3.2Product code MBZ001
    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 INNtramadol
    D.3.9.1CAS number 36282-47-0
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Tramadol Vitabalans, 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderVitabalans Oy
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 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 INNtramadol
    D.3.9.1CAS number 36282-47-0
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Chronic knee and/or hip pain due to Osteoarthritis.
    Choroba zwyrodnieniowa stawu biodrowego i/lub kolanowego.
    E.1.1.1Medical condition in easily understood language
    Chronic knee and/or hip pain due to Osteoarthritis.
    Choroba zwyrodnieniowa stawu biodrowego i/lub kolanowego.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020108
    E.1.2Term Hips osteoarthritis
    E.1.2System Organ Class 100000004859
    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 this study is to evaluate efficacy, safety and tolerability of the new formulation composed of tramadol 50 mg and micronized magnesium lactate 75 mg of Mg2+ ionsin the application ofdaily dose 150 mg /225 mgfor the management of chronic pain in subjects with osteoarthritis ofthe hip or/and knee. Non-inferiority study is planned to show that the effect of a new treatment is not worse than that of an active control.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess subject acceptance during disease treatment as well as to collect data on subject’s quality of life and the impact on the economy (Cost-Effectiveness Analysis - CEA) and Cost Utility Analysis - CUA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only subjects to whom all of the following conditions apply will be included:
    1. Males (not less than 35% of all subjects) and femalesaged 18-75 years.
    2. For females, to have a negative pregnancy test at the Baseline (Visit 1) prior to administration of study medication.
    3. Females ofnon-childbearing potential or if of childbearing potential, must use a medically acceptable form of contraception for the duration of the study.Females of non-childbearing potential are defined as those who are either surgically sterilised or at least one year post-menopausal.
    4. Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate.
    5. Adults with a clinical diagnosis of osteoarthritis of the hip and /or knee, based on American College of Rheumatology and radiographic criteria. The presence of typical knee or hip joint symptoms (pain, stiffness, disability) and signs (bony crepitus), and radiographic evidence of osteoarthritis (functional class I-III).
    6. Subjects who have a baseline numeric rating scale pain intensity score (NRS-11) ≥4 (at Day 1) before randomisation to study treatments.
    7. Subjects with hip or/and knee osteoarthritis who were judged by investigator as having suboptimal response to non-opioid treatment.
    8. Willingness to withhold any medicines that may interfere with tramadol metabolism for 2 weeks prior to the start of the study and continue to withhold them during treatment periods.
    E.4Principal exclusion criteria
    Subjects to whom any of the following conditions apply must be excluded:
    1. Inflammatory arthritis, gout, pseudogout, or Paget’s disease of bone that might interfere with the assessment of response.
    2. Diagnosis of chronic pain syndrome (lasting longer than 3 months).
    3. Clinical diagnosis of fibromyalgia or another major joint or connective tissue disease.
    4. Inability to discontinue acetaminophen, COX-2 inhibitors, NSAIDs (other than aspirin <325 mg QD for cardiovascular prophylaxis), corticosteroids, or other analgesics for the duration of the clinical study.
    5. Use of oral, intramuscular, intravenous, or soft tissue corticosteroids within 1 month prior to the study.
    6. History of clinically significant intolerance to tramadol or a known hypersensitivity to opioid analgesics; and increased risk in terms of the precautions, warnings, and contraindications noted in the tramadol prescribing information.
    7. History of clinically significant intolerance or a known hypersensitivity to non-steroid anti-inflammatory drugs; and increased risk in terms of the precautions, warnings, and contraindications noted in the diclofenac prescribing information. 8. Uncontrolled concomitant disease or chronic condition(s)need of medical treatment that might interfere with the assessment of pain and other symptoms of osteoarthritis including: Epilepsy in medical history; History of serious insufficiency of the kidney or liver; Parkinson disease; History of extrapyramidal symptoms; History of or current depressive disorders and antidepressive treatment being continued; History of unstable ischaemic disease, cardiac arrhythmia, unstable arterial hypertension.
    9. History of, or reason to believe a participant has a history of narcotic or alcohol abuse as well as sedative drugs use including hypnotics, other analgesics like morphine or codeine and any other drugs that have a sedating potential.
    10. HIV, Hepatitis B or C in subject history.
    11. Treatment with MAO inhibitors within the period shorter than 30 days prior to study enrolment.
    12. Antipsychotic or antidepressant or anticonvulsant used drugs or treatment during 2 weeks prior to study enrolment.
    13. Miastenia gravis.
    14. Tramadol or magnesium treatment being considered as contraindicated by investigator.
    15. Use of any dietary supplements containing magnesium14 days prior to study enrolmentor during the study.
    16. Ongoing treatment with calcium blockers, gabapentine, pregabaline and anticoagulant.
    17. Body mass index (BMI) > 35.0 kg/m2.
    18. Pregnancy and breast-feeding female.
    19. Infirmity, disability or geographic location that would limit compliance for scheduled visits - subject at risk of non-compliance.
    20. Any clinically significant abnormality or other serious or unstable medical or psychological condition identified in the subjects’ medical history, on physical examination or laboratory tests that, in the judgement of the investigator, would compromise the subjects’ safety or successful participation in this Study.
    21. Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the change between baseline (V1) to End of treatment (V4 or the day of discontinuation) of pain intensity measured on 11-point pain intensity numerical rating scale (PI-NRS) that is achieved on the day of therapy discontinuation or at the end of the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On the day of therapy discontinuation or at the end of the trial.
    E.5.2Secondary end point(s)
    The secondary study endpoints are:
    The daily arthritis pain intensity (assessed using a daily subject diary, measured on 11-point pain intensity numerical rating scale) assessment.
    Proportion of subjects with reduced pain (≥1 point) at the each control visit.
    Proportion of subjects with eliminated pain (0 point) at the each control visit.
    Proportion of compliant subjects, i.e. those having a compliance more than 80% at the regular therapy end visit.
    Proportion of subjects recorded rescue medication (Diclofenac ER 100 mg) taken daily.
    Change from baseline in the WOMAC® Osteoarthritis Index covering the evaluation of the pain, stiffness and physical function assessmentat the Visit 1, Visit 2 and Visit 4.
    Change from baseline inthe WOMAC® Composite Index (the sum of three subscales scores)at the Visit 1, Visit 2 and Visit 4.
    Change from baseline in EQ-5D-5L at the Visit 1, Visit 2 and Visit 4.
    Average cost for health services per subject.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On the day of therapy discontinuation or at the end of the trial.
    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 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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial2
    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 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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 174
    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 state294
    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)
    Subject who experience adverse events at the end of the study, or experience the onset of an event after the final visit will be followed up. Subjects will not receive any additional treatment from Sponsor after completion of the study because other treatment options are available.
    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 Decision2017-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-15
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