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Clinical trials for Tapentadol

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
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    • 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    49 result(s) found for: Tapentadol. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2012-005499-33 Sponsor Protocol Number: HP5503-88 Start Date*: 2014-11-11
    Sponsor Name:Grünenthal GmbH
    Full Title: Relative bioavailability trial to investigate the pharmacokinetics of tapentadol following the administration of 3 prototype tapentadol 25 mg prolonged release (PR) granule formulations compared to...
    Medical condition: No medical condition to be investigated.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000205-77 Sponsor Protocol Number: KF5503-75 Start Date*: Information not available in EudraCT
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label investigation of the pharmacokinetic profile, safety, tolerability, and efficacy of multiple administrations of tapentadol oral solution used for treatment of acute pain in children aged...
    Medical condition: Moderate to severe acute pain
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004867 10066714 Acute pain LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000623-24 Sponsor Protocol Number: KF5503-72 Start Date*: 2014-10-30
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children aged from birth t...
    Medical condition: Moderate to severe acute post-operative pain.
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010428-25 Sponsor Protocol Number: KF5503/45 Start Date*: 2010-02-15
    Sponsor Name:Grünenthal GmbH
    Full Title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic nocicept...
    Medical condition: Low back Pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024891 Low back pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) NL (Completed) DE (Completed) FR (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-013291-46 Sponsor Protocol Number: KF5503/52 Start Date*: 2010-09-14
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF 5503/15 t...
    Medical condition: This treatment is intended to treat subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF5503/15 trial.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) AT (Completed) ES (Completed) HU (Completed) FR (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-002259-24 Sponsor Protocol Number: KF5503-73 Start Date*: 2015-03-16
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in child...
    Medical condition: Severe post-operative pain
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004863 10036286 Post-operative pain LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Completed) GB (Completed) ES (Completed) CZ (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004360-22 Sponsor Protocol Number: KF5503-66 Start Date*: 2014-10-02
    Sponsor Name:Grünenthal GmbH
    Full Title: An open label trial, enrolling subjects aged 6 years to less than 18 years suffering from pain requiring prolonged release opioid treatment, to evaluate the safety and efficacy of tapentadol PR ver...
    Medical condition: Pain requiring prolonged release opioid treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000023314 10049475 Chronic pain LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PT (Completed) ES (Completed) SK (Prematurely Ended) BE (Completed) IT (Completed) SI (Prematurely Ended) HU (Completed) BG (Completed) HR (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-010423-58 Sponsor Protocol Number: KF5503/42 Start Date*: 2009-08-28
    Sponsor Name:Grünenthal GmbH
    Full Title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chr...
    Medical condition: Pain due to Osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10031161 Osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-010425-39 Sponsor Protocol Number: KF5503/43 Start Date*: 2009-09-23
    Sponsor Name:Grünenthal GmbH
    Full Title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic pain due...
    Medical condition: Pain due to Osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10031161 Osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-005082-31 Sponsor Protocol Number: MP-TAP-2016-01 Start Date*: 2017-11-20
    Sponsor Name:MRI Research Unit, Radiology Department. Hospital del Mar.
    Full Title: Assessment of Tapentadol effects on patients with pain central sensitization using functional MRI
    Medical condition: Patients suffering from pain due to knee osteoarthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010427-12 Sponsor Protocol Number: KF5503/44 Start Date*: 2009-10-14
    Sponsor Name:Grünenthal GmbH
    Full Title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chr...
    Medical condition: Low back Pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024891 Low back pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) AT (Completed) DE (Completed) IT (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-015397-35 Sponsor Protocol Number: KF5503/53 Start Date*: 2010-02-12
    Sponsor Name:Grünenthal GmbH
    Full Title: A multicenter, open-label trial to assess cognitive and psychomotor performance as surrogate parameters for driving ability under stable long term treatment with tapentadol hydrochloride prolonged-...
    Medical condition: Pain
    Disease: Version SOC Term Classification Code Term Level
    14.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002016-27 Sponsor Protocol Number: KF5503/68 Start Date*: 2015-03-23
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label evaluation of the pharmacokinetic profile, safety, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children and adolescents aged from 2 years to less ...
    Medical condition: Postoperative Pain
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10036236 Postoperative pain relief LLT
    17.1 100000004863 10054711 Postoperative pain LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004804-21 Sponsor Protocol Number: ANST_PREVENT Start Date*: 2020-01-13
    Sponsor Name:Leiden University Medical Center
    Full Title: A Randomized, Double-blind, Placebo-controlled Trial on the Prevention of Chronic Postoperative Pain after Inguinal Hernia and Knee Surgery by Postoperative Treatment with Tapentadol.
    Medical condition: Chronic pain after inguinal hernia surgery and knee replacement surgery.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-019998-14 Sponsor Protocol Number: KF5503/58 Start Date*: 2011-02-15
    Sponsor Name:Grünenthal GmbH
    Full Title: Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain...
    Medical condition: severe chronic low back pain with a neuropathic pain component
    Disease: Version SOC Term Classification Code Term Level
    12.1 10024891 Low back pain LLT
    12.1 10054095 Neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) AT (Completed) BE (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2009-017470-20 Sponsor Protocol Number: GRT-CG5503-2009-02-FR Start Date*: 2010-05-07
    Sponsor Name:Laboratoires Grünenthal
    Full Title: An open-label extension study for patients with severe chronic low back pain or severe chronic pain due to knee osteoarthritis who have completed any of the previous phase IIIb trials with tapentad...
    Medical condition: Severe chronic pain
    Disease: Version SOC Term Classification Code Term Level
    12.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004359-35 Sponsor Protocol Number: R331333PAI3037 Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen Research & Development LLC
    Full Title: An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 y...
    Medical condition: The management of acute postoperative pain in hospitalized paediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10036236 Postoperative pain relief LLT
    17.0 100000004863 10054711 Postoperative pain LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing) DE (Completed) GB (Completed) ES (Completed) AT (Completed) FR (Ongoing) PL (Completed) HR (Completed) HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-003515-22 Sponsor Protocol Number: SURF Start Date*: 2018-11-29
    Sponsor Name:Leiden University Medical Center
    Full Title: Respiratory effects of tapentadol and oxycodone assessed by pharmacokinetic-pharmacodynamic and response surface modeling in healthy volunteers
    Medical condition: Chronic pain
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001920-36 Sponsor Protocol Number: KF6005/06 Start Date*: 2012-09-21
    Sponsor Name:Grünenthal GmbH
    Full Title: Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain
    Medical condition: moderate to severe chronic low back pain
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004859 10024891 Low back pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) BE (Completed) GB (Completed) ES (Completed) SE (Completed) DK (Completed) HU (Completed) FI (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-015527-82 Sponsor Protocol Number: GRT-CG5503-2009-01-ES Start Date*: 2009-11-20
    Sponsor Name:Grünenthal Pharma S.A.
    Full Title: Estudio abierto de extensión para los pacientes con lumbalgia crónica severa o dolor crónico severo debido a artrosis de rodilla que han completado alguno de los ensayos clínicos previos de fase II...
    Medical condition: Artrosis de rodilla y lumbalgia
    Disease: Version SOC Term Classification Code Term Level
    12.0 10024891 Low back pain LLT
    12.0 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (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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