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Clinical trials for Modic changes

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    10 result(s) found for: Modic changes. Displaying page 1 of 1.
    EudraCT Number: 2008-005351-14 Sponsor Protocol Number: CZOL446HFI03 Start Date*: 2008-10-31
    Sponsor Name:University of Oulu, Department of Physical and Rehabilitation Medicine
    Full Title: Efficacy of zoledronic acid 5 mg for chronic low back pain due to Modic changes
    Medical condition: Modic changes are vertebral endplate changes and bone marrow changes visible in magnetic resonance imaging (MRI), which are closely assosiated with disc degeneration. Modic changes are assosiated w...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-005500-17 Sponsor Protocol Number: VF20050122 Start Date*: 2006-02-03
    Sponsor Name:The Back Research center
    Full Title: Antibiotic treatment of patients with low back pain and Modic changes after a lumbar disc herniation. A randomized clinical controlled trial.
    Medical condition: Low back pain wiht Modic changes identified on MRI
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004505-14 Sponsor Protocol Number: Modic02 Start Date*: 2015-03-04
    Sponsor Name:Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser
    Full Title: Antibiotic treatment in patients with chronic low back pain and Modic Changes: a double-blind randomized placebo-controlled trial
    Medical condition: 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 hypothesi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-004861-29 Sponsor Protocol Number: Modic03 Start Date*: 2018-05-16
    Sponsor Name:FOU, Nevroklinikken, Oslo University Hospital -Ullevål
    Full Title: BackToBasic: The effect of Infliximab in patients with chronic low back pain and Modic changes. A randomized, double blind, placebo-controlled, multicenter trial
    Medical condition: Non-specific chronic low back pain of more than 6 months duration. We will only investigate those who have vertebral end-plate chanages(Modic changes) on MRI.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10008837 Chronic back pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005488-25 Sponsor Protocol Number: 8833 Start Date*: 2017-02-02
    Sponsor Name:UH Montpellier
    Full Title: Evaluation of the effectiveness of intradiscal injection of corticosteroids in the Modic I discopathies
    Medical condition: chronic low back pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000751-25 Sponsor Protocol Number: AXS02II201501 Start Date*: 2016-05-02
    Sponsor Name:Jaro Karppinen
    Full Title: ZOLEDRONIC ACID, A LONG-ACTING BISPHOSPHONATE, FOR CHRONIC LOW BACK PAIN DUE TO MODIC CHANGES: A RANDOMIZED CONTROLLED TRIAL
    Medical condition: Chronic low back pain
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004859 10024891 Low back pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012672-27 Sponsor Protocol Number: CIP0702PLF/EU Start Date*: 2009-08-17
    Sponsor Name:ApaTech Limited
    Full Title: "A prospective, randomised study comparing the use of Actifuse™ ABX synthetic bone substitute with INFUSE® in patients requiring posterolateral instrumented lumbar fusion with interbody fusion" als...
    Medical condition: Prospective trial participants will have been diagnosed with degenerative disc disease with a treatment option of decompression and Interbody Fusion with Posterolateral Intertransverse Process Fusi...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024992 Lumbar disc disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004943-54 Sponsor Protocol Number: STA-02 Start Date*: 2020-06-15
    Sponsor Name:Stayble Therapeutics AB
    Full Title: A multi-country, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of STA363 at two concentrations (60 mg/mL and 120 mg/mL) compared to placebo in patients wi...
    Medical condition: Сhronic discogenic low back pain
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10024891 Low back pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006503-15 Sponsor Protocol Number: STA-LDH01 Start Date*: 2023-02-23
    Sponsor Name:Stayble Therapeutics
    Full Title: A prospective, randomised, double-blinded, placebo-controlled study investigating the safety and tolerability of STA363 in patients with radiculopathy caused by lumbar disc herniation
    Medical condition: Radiculopathy due to lumbar intervertebral disc herniation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    20.0 10029205 - Nervous system disorders 10050219 Lumbar radiculopathy PT
    20.0 10029205 - Nervous system disorders 10052772 Lumbar spinal cord and nerve root disorders HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001449-26 Sponsor Protocol Number: 6603/1132 Start Date*: 2015-01-22
    Sponsor Name:Seikagaku Corporation
    Full Title: A Multicenter, Open-label Study of SI-6603 in Patients with Lumbar Disc Herniation (Phase III)
    Medical condition: Lumbar disc herniation
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10050296 Intervertebral disc protrusion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: View results
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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