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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
  • 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   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 2 of 3.
    EudraCT Number: 2017-000141-52 Sponsor Protocol Number: Landscaping_2017 Start Date*: 2017-04-03
    Sponsor Name:Asbjørn Mohr Drewes
    Full Title: The effect of tapentadol on the human pain system: A study based on advanced neurophysiology and imaging techniques to illustrate the mechanism of tapentadol and oxycodone in the central, autonomic...
    Medical condition: Healthy volunteers - pain
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-020380-20 Sponsor Protocol Number: R331333-PAI2005/KF5503-59 Start Date*: 2012-03-09
    Sponsor Name:Janssen Research & Development, L.L.C.
    Full Title: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
    Medical condition: Pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-002943-11 Sponsor Protocol Number: KF5503/60 Start Date*: 2013-02-25
    Sponsor Name:Grünenthal GmbH
    Full Title: Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus oxycodone/naloxone PR in non-opioid pre-treated subjects with uncontrolled severe chronic low back pain with a neur...
    Medical condition: Severe chronic low back pain with a neuropathic pain component
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004852 10054095 Neuropathic pain LLT
    16.0 100000004859 10024891 Low back pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-001285-23 Sponsor Protocol Number: 170317-1 Start Date*: 2017-07-04
    Sponsor Name:Oslo University Hospital
    Full Title: A comparison of analgesic and respiratory effects from tapentadol versus oxycodone after laparoscopic hysterectomy.
    Medical condition: Pain after laparoscopic hysterectomy.
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults Gender: Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2011-003628-11 Sponsor Protocol Number: TapOxy001 Start Date*: 2011-10-26
    Sponsor Name:University Hospital Schleswig Holstein Kiel, Clinic of Neurology
    Full Title: Tapentadol PR vs Oxycodon CR A pilotstudiy for a mechanism-orientated Therapy of peripheral chronic neuropathic pain syndrom
    Medical condition: Chronical neuropathic pain syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023175-26 Sponsor Protocol Number: P_TPT_2010 Start Date*: 2011-01-14
    Sponsor Name:Leiden University Medical Center
    Full Title: Influence of Tapentadol on endogenous modulation of pain in chronic neuropathic pain patients and healthy volunteers
    Medical condition: Chronic pain patients/ mhealthy volunteers
    Disease: Version SOC Term Classification Code Term Level
    12.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004585-18 Sponsor Protocol Number: KKS-190 Start Date*: 2013-08-27
    Sponsor Name:Philipps-Universität Marburg
    Full Title: Perioperative administration of Tapentadol – tolerance, safety and effects on postoperative rehabilitation and quality of life. Randomized, controlled study to compare the analgesic therapy with t...
    Medical condition: Hysterectomy with ASA 1-3, Prostatectomy with ASA 1-3, Nephrectomy with ASA 1-3
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10021151 Hysterectomy PT
    14.1 10042613 - Surgical and medical procedures 10029116 Nephrectomy PT
    14.1 10042613 - Surgical and medical procedures 10061916 Prostatectomy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005783-67 Sponsor Protocol Number: KF5503/12-R331333-PAI-3009 Start Date*: 2007-04-18
    Sponsor Name:Grünenthal GmbH
    Full Title: A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial with Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Prolonged-Release (PR) in Subj...
    Medical condition: Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) LV (Completed) HU (Completed) DE (Completed) ES (Completed) PT (Completed) IT (Completed) AT (Completed) SK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-000755-14 Sponsor Protocol Number: IMI2-PainCare-BioPain-RCT2 Start Date*: 2019-09-06
    Sponsor Name:Sapienza University of Rome, Department of Human Neurosciences
    Full Title: A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processi...
    Medical condition: Healthy volunteers (intended indication: pain)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003482-14 Sponsor Protocol Number: KF5503/24-R331333-PAI-3007 Start Date*: 2007-02-23
    Sponsor Name:Johnson & Johnson Pharamceutical Resarch & Development, L.L.C
    Full Title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase III Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR* and Oxycodone CR in Subjects with Chronic Pain
    Medical condition: Chronic pain due to knee or hip osteoarthritis or low back pain of benign origin
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) NL (Completed) AT (Completed) BE (Completed) GB (Completed) SK (Completed) SI (Prematurely Ended) FR (Completed) CZ (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-004997-28 Sponsor Protocol Number: KF5503/15-R331333-PAI-3013 Start Date*: 2007-03-15
    Sponsor Name:Grünenthal GmbH
    Full Title: A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR in subjects with moderate to severe chronic malig...
    Medical condition: malignant tumor related pain
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) AT (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) SK (Completed) NL (Completed) BG (Completed) SE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-004998-95 Sponsor Protocol Number: KF5503/35 Start Date*: 2007-08-08
    Sponsor Name:Grünenthal GmbH
    Full Title: A randomized, double-blind, parallel-arm, placebo- and comparator-controlled trial of the efficacy and safety of multiple doses of immediate-release (IR) CG5503 for postoperative pain following abd...
    Medical condition: Postoperative pain following abdominal hysterectomy
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000075 Abdominal hysterectomy LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) SK (Completed) LV (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2015-000295-94 Sponsor Protocol Number: TPO-150 Start Date*: 2015-10-13
    Sponsor Name:St Olavs University Hospital
    Full Title: Use of long acting opioids for pre- and postoperative analgesia in primary total knee arthroplasty. A double-blinded randomized control trial. Tapentadol vs Oxycodon vs Placebo
    Medical condition: Pain therapy for total knee arthroplasty (total knee replacement)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004863 10036286 Post-operative pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2019-001204-37 Sponsor Protocol Number: IMI2-PainCare-BioPain-RCT3 Start Date*: 2019-09-06
    Sponsor Name:Institute of Neuroscience (IoNS), Université catholique de Louvain
    Full Title: A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processi...
    Medical condition: Healthy subjects (intended indication: pain)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003770-11 Sponsor Protocol Number: GROSKNEEPA01 Start Date*: 2012-11-26
    Sponsor Name:C4Pain ApS
    Full Title: A multi-center, randomized parallel group pilot study to investigate the mechanism of action of tapentadol PR and oxycodone CR in subjects with osteoarthritis knee pain
    Medical condition: Osteoarthritic Knee Pain.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10029877 OA knee LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-000942-36 Sponsor Protocol Number: IMI2-PainCare-BioPain-RCT1 Start Date*: 2019-09-06
    Sponsor Name:Aarhus University
    Full Title: A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processi...
    Medical condition: Healthy volunteers (intended indication: pain)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001358-41 Sponsor Protocol Number: VERCLBP002 Start Date*: 2023-02-27
    Sponsor Name:Vertanical GmbH
    Full Title: Multicentre, randomized, open-label study to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in the treatment of patients with chronic non-specific low back pain.
    Medical condition: Chronic non-specific low back pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Temporarily Halted) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005259-28 Sponsor Protocol Number: LCAT Start Date*: 2016-02-22
    Sponsor Name:LUMC
    Full Title: A randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic ...
    Medical condition: Low back pain
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004859 10024891 Low back pain LLT
    18.1 100000004859 10024892 Low back pain (without radiation) LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000908-15 Sponsor Protocol Number: IMI2-PainCare-BioPain-RCT4 Start Date*: 2019-09-24
    Sponsor Name:Aarhus University
    Full Title: A randomized, double-blind, placebo-controlled, cross-over trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by...
    Medical condition: Healthy volunteers (intended indication: pain)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-003238-15 Sponsor Protocol Number: Schaefers0711 Start Date*: 2012-12-12
    Sponsor Name:KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH
    Full Title: Quality of analgesia and side effect incidence and severity during postoperative pain management with Palexia® compared to Targin®
    Medical condition: Management of postoperative pain in trauma surgery patients (adults) requiring postoperative opiates for the management of postoperative pain.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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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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