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    Summary
    EudraCT Number:2013-004505-14
    Sponsor's Protocol Code Number:Modic02
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-31
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-004505-14
    A.3Full title of the trial
    Antibiotic treatment in patients with chronic low back pain and Modic Changes: a double-blind randomized placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Antibiotic treatment in patients with chronic low back pain and bone edema on MRI adjacent to a previously herniated disc or adjacent to a degenerated disc: a double-blind study where patients at random are offered antibiotics or placebo tablets without knowing which tablets they are given."
    A.4.1Sponsor's protocol code numberModic02
    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 SponsorOslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser
    B.1.3.4CountryNorway
    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 supportA. Oslo universitetssykehus HF, Ullevål sykehus, FORMI-Formidlingsenheten for muskel- og skjelettlidelser. B. Helse Vest
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser
    B.5.2Functional name of contact pointKjersti Storheim
    B.5.3 Address:
    B.5.3.1Street AddressBygg 37B, Postboks 4956 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number+4722117751
    B.5.6E-mailkjersti.storheim@medisin.uio.no
    D. IMP Identification
    D.IMP: 1
    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 Amoxicillin 750mg ATC-nr.: J01C A04
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameAmoxicillin
    D.3.2Product code ATC-nr.: J01C A04
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A recent Danish study published during spring 2013 advances a remarkable cause and treatment with Amoxicillin for a selected sub-group of low back pain patients.The study was based upon a hypothesis that chronic low back pain may arise from a low-grade infection of the intervertebral disc by the anaerobic Proprione acne bacteria, resulting in pain and bone edema (Modic changes). The main scope of this RCT is to re-examine the effect of amoxicillin in this patient group.
    E.1.1.1Medical condition in easily understood language
    The sub-group of patients with chronic low back pain, earlier disc herniation, and focal vertebral bone marrow changes (Modic Changes) on magnetic resonance imaging (MRI).
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To re-examine the finding that antibiotic treatment can cure patients with chronic low back pain, earlier disc herniation, and Modic changes.
    We will evaluate the effect of antibiotic treatment versus placebo on pain and disability, bothersomeness, health-related quality of life, sick leave, patients’ satisfaction and side effects from inclusion to 1-year follow-up. Our trial will be the first to re-examine the Danish Modic-antibiotica study.


    E.2.2Secondary objectives of the trial
    To compare change in Modic changes on MRI from inclusion to 1-year follow-up between treatment groups, and to assess whether characteristics of Modic changes by different MRI methods are related to the clinical effects of antibiotic treatment.
    Further, to contribute to a clarification of the pathogenesis of Modic changes by studying gene expression of inflammatory biomarkers, and to conduct health economic analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria will be as follows:
    •Age between 18 and 65 years
    •LBP of > 6 months duration in the area from L1 to L5 with a Numerical Rating Scale (NRS) score of  5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks).
    •MRI-confirmed disc herniation within the preceding 2 years or degenerated disc (Pfirrmann grade  348) at level L3/L4, L4/L5 or L5/S1.
    •MC type I or type II adjacent to a previously herniated disc or adjacent to a degenerated disc (Pfirrmann grade  348), based on T1- and T2 weighted MRI.
    •Both conservative and surgically treated patients will be included.
    E.4Principal exclusion criteria
    Exclusion criteria:
    •Allergy to antibiotics or gradolinium contrast
    •Current pregnancy or lactation
    •Any kidney disease or pending litigation
    •Any specific LBP diagnosis that may explain patients symptoms.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures in the clinical part of the study will be pain and disability measured by the Norwegian version of the disease-specific Roland and Morris Questionnaire (RMQ)24;50. The RMQ ranges from 0 to 24, with lower score indicating less severe pain and disability. A clinically important change will be defined as a 30 % reduction of the individual’s baseline score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in RMQ wil be evaluated at 1-year follow-up.
    E.5.2Secondary end point(s)
    Secondary outcomes will be lumbar pain and leg pain, hours with pain during the last 4 weeks, bothersomeness, health-related quality of life (EuroQoL-5D), days with sick leave, patient’s satisfaction, and functional capacity (Oswestry Disability Index).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data will be collected at baseline during follow-up, and at 1-year follow-up. Secondary outcomes will be evaluated at 1 year follow-up.
    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 Yes
    E.6.13.1Other scope of the trial description
    Radiological, genetics and health economics.
    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) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned5
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months36
    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 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: 280
    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 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.3.3.6.1Details of subjects incapable of giving consent
    None
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state280
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 280
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of radiology, Haukeland University Hospital
    G.4.3.4Network Country Norway
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-21
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