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Clinical trials for Antidote

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    19 result(s) found for: Antidote. Displaying page 1 of 1.
    EudraCT Number: 2011-000206-22 Sponsor Protocol Number: 130101 Start Date*: 2011-04-11
    Sponsor Name:Helsingin Yliopisto, Kemian laitos
    Full Title: Elimination kinetics of HCN after inhaled exposure
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001151-40 Sponsor Protocol Number: CTU148N Start Date*: 2019-07-09
    Sponsor Name:RIEMSER Pharma GmbH
    Full Title: Phase II pilot study: To determine an effective and tolerable dose of Hylase® "Dessau" (bovine hyaluronidase) in the treatment of hyaluronic acid filler overshoots by injection into defined areas o...
    Medical condition: In this study, healthy subjects get an artificial over-injection with Hyaluron acid filler on the back of the hands. To demonstrate the effectiveness of hylase® "Dessau" as an antidote for hyaluro...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000379-96 Sponsor Protocol Number: INnaloxonePed-1 Start Date*: 2017-05-05
    Sponsor Name:Karolinska University Hospital
    Full Title: Pharmacokinetic and pharmacodynamic aspects in children after intranasal administration of the opioid antagonist naloxone
    Medical condition: Pharmacokinetic profile after nasal naloxone administration in Children. In second part study reversal of sedation after opioid use
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005663-27 Sponsor Protocol Number: HDNX Start Date*: 2013-02-27
    Sponsor Name:HOC, Rigshospitalet
    Full Title: Effect of a late naloxone-infusion on secondary hyperalgesia after a first degree heat injury.
    Medical condition: First degree burn injury in healthy volunteers
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10020573 Hyperalgesia LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005201-31 Sponsor Protocol Number: INNalox-1 Start Date*: 2015-03-31
    Sponsor Name:Karolinska University Hospital
    Full Title: Pharmacokinetic profile and pharmacodynamic effects after intranasal naloxone administration in volunteers and pediatric patients.
    Medical condition: Sedation after opioid administration Pharmacokinetic profile after naloxone administered intranasally
    Disease:
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2007-001559-20 Sponsor Protocol Number: 95195608 Start Date*: 2007-04-17
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: Steady-state pharmacokinetics of high dose acetaminophen inpost-op children. Rational use of N-acetyl cysteine for prevention of liver toxicity related to cumulative doses.
    Medical condition: Major surgery when the use of paracetamol is required for pain release
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000374-21 Sponsor Protocol Number: 19-515 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc
    Full Title: PROSPECTIVE, OPEN-LABEL STUDY OF ANDEXANET ALFA IN PATIENTS RECEIVING A FACTOR XA INHIBITOR WHO REQUIRE URGENT SURGERY (ANNEXA-S)
    Medical condition: Need for FXa inhibitor reversal in patients undergoing urgent surgery.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002620-17 Sponsor Protocol Number: 18-513 Start Date*: 2019-01-08
    Sponsor Name:Portola Pharmaceuticals, Inc
    Full Title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
    Medical condition: Oral FXa inhibitor-treated patients with acute intracranial bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) GR (Completed) CZ (Completed) LV (Completed) FI (Prematurely Ended) NO (Prematurely Ended) LT (Prematurely Ended) PL (Completed) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003220-36 Sponsor Protocol Number: 45112 Start Date*: 2014-05-21
    Sponsor Name:Albert Schweitzer hospital
    Full Title: Remifentanil use for procedural sedation and analgesia in the emergency department
    Medical condition: The research will be conducted in patients that need short painfull treatment in the emergency department and with an indication for PSA. These treatments include: repositioning of fractures, repos...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000815-42 Sponsor Protocol Number: HighNxGHR_PK Start Date*: 2015-04-28
    Sponsor Name:Rigshospitalet, Copenhagen University Hospitals
    Full Title: Pharmacokinetics of High-dose Target-controlled Naloxone Infusion. Companion study to: Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia in Patients following Groin-H...
    Medical condition: Healthy subjects
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004072-22 Sponsor Protocol Number: NINA-1 Start Date*: 2017-12-07
    Sponsor Name:Norwegian University of Science and Technology (NTNU)
    Full Title: NTNU Intranasal Naloxone Trial Double blinded, double dummy, randomised controlled trial of intranasal naloxone for pre hospital use
    Medical condition: We investigate the reversal of opioid overdoses in the pre hospital setting
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10022117 Injury, poisoning and procedural complications SOC
    20.0 10022117 - Injury, poisoning and procedural complications 10071947 Exposures, chemical injuries and poisoning HLGT
    20.0 10022117 - Injury, poisoning and procedural complications 10035777 Poisoning and toxicity HLT
    21.1 10022117 - Injury, poisoning and procedural complications 10070863 Toxicity to various agents PT
    20.1 10022117 - Injury, poisoning and procedural complications 10072946 Opioid toxicity LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2018-000013-20 Sponsor Protocol Number: 2018-000013-20 Start Date*: 2018-05-07
    Sponsor Name:KU Leuven
    Full Title: Placebo-controlled crossover study of the ability of Naloxegol to reverse opioid effect on colonic motor patterns in healthy volunteers
    Medical condition: This study will be performed in healthy volunteers.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001785-26 Sponsor Protocol Number: 14-505 Start Date*: 2016-02-15
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).
    Medical condition: Uncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022097 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-004706-14 Sponsor Protocol Number: MT201-204 Start Date*: 2009-02-09
    Sponsor Name:Micromet AG
    Full Title: A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colore...
    Medical condition: R0 resected liver metastases from colorectal cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000246-21 Sponsor Protocol Number: PP100-001 Start Date*: 2017-04-25
    Sponsor Name:PledPharma AB
    Full Title: A Randomised Open Label Exploratory, Safety and Tolerability Study with PP100-01 in Patients Treated with the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose
    Medical condition: The objective of this study is to develop a therapeutic regimen for paracetamol/acetaminophen overdose (POD) where a novel NAC 12hr regime is combined with a superoxide dismutase (SOD) mimetic, PP1...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10033295 Overdose PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000793-36 Sponsor Protocol Number: HighNxGHR Start Date*: 2015-04-28
    Sponsor Name:Rigshospitalet, Copenhagen University Hospitals
    Full Title: Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia in Patients following Groin-Hernia-Repair. A companion study to: Pharmacokinetics of High-dose Target-controlled Nal...
    Medical condition: Groin hernia repair
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-001857-22 Sponsor Protocol Number: Methadone-010922 Start Date*: 2022-09-06
    Sponsor Name:Sygehus Sønderjylland, Orthopedic department
    Full Title: Perioperative Methadone for ameliorating postoperative pain and reduction in postoperative opioid consumption in hip fracture patients – Dosage adjusting pilot-study
    Medical condition: Hip fractures
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10068399 Trochanteric femoral fracture LLT
    25.0 100000004863 10086938 Pertrochanteric femoral fracture LLT
    25.0 100000004863 10086939 Intertrochanteric femoral fracture LLT
    20.1 100000004863 10017284 Fractured femoral neck LLT
    20.1 100000004863 10053653 Femur fracture subtrochanteric LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004898-41 Sponsor Protocol Number: NBK241/1/2020 Start Date*: 2021-03-31
    Sponsor Name:MEDICAL UNIVERSITY OF GDAŃSK
    Full Title: A multicentre, parallel group, randomised, double blind, placebo-controlled, phase II study evaluating the efficacy and safety of reperfusion thrombolytic therapy with intravenous recombinant tissu...
    Medical condition: Acute ischemic stroke
    Disease: Version SOC Term Classification Code Term Level
    22.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005426-19 Sponsor Protocol Number: 51237 Start Date*: 2016-02-09
    Sponsor Name:Rigshospitalet, Copenhagen University Hospitals
    Full Title: "Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia in Patients following Recovery from Impacted Mandibular Third Molar Extraction. A Randomized, Placebo-controlled, ...
    Medical condition: Healthy volunteers (n = 94) are included. The main study includes 14 subjects who have had an uncomplicated, impacted mandibular, third molar extraction 4-5 weeks prior to participation in the stud...
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (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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