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Clinical trials for Naloxone

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    94 result(s) found for: Naloxone. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    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: 2008-005315-18 Sponsor Protocol Number: HMX3501 Start Date*: 2009-07-21
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio w...
    Medical condition: Moderate to severe chronic non-cancer or cancer pain with opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    14.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    14.0 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) GB (Completed) FR (Completed) NL (Completed) DE (Completed) AT (Completed) BE (Completed) DK (Completed) RO (Completed)
    Trial results: View results
    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: 2006-001384-30 Sponsor Protocol Number: 05/010/SAN Start Date*: 2006-08-01
    Sponsor Name:Brighton and Sussex Universities Hospitals Trust Research and Development Directorate
    Full Title: Standard vs reduced dose naloxone for the reversal of opiate overdose. Does dose modification increase the likelihood of reaching hospital and entering a substance misuse programme?
    Medical condition: Accidental, recreational heroin (and other opiate) overdose.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    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: 2012-003218-14 Sponsor Protocol Number: 0176/DEV Start Date*: 2013-01-22
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety, and tolerability of Naloxone HCl PR tablets a...
    Medical condition: Opioid-induced bowel dysfunction (OBD) involves not only constipation, but also a constellation of symptoms including incomplete evacuation, bloating, abdominal distension, and increased gastric re...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) SK (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004311-31 Sponsor Protocol Number: 0177/DEV Start Date*: 2013-03-20
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety, and tolerability of Naloxone HCl PR tablets a...
    Medical condition: Opioid-induced bowel dysfunction (OBD) involves not only constipation, but also a constellation of symptoms including incomplete evacuation, bloating, abdominal distension, and increased gastric re...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) CZ (Completed) DE (Completed) GB (Completed) SK (Completed) ES (Completed) IT (Completed) PL (Prematurely Ended)
    Trial results: View results
    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: 2009-009377-10 Sponsor Protocol Number: NAL-OIC-01 Start Date*: 2009-05-27
    Sponsor Name:SLA Pharma (UK) Ltd
    Full Title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Efficacy Study of Naloxone SR capsules in Subjects with Constipation due to Opioids ta...
    Medical condition: Opioid Induced Constipation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021175 Iatrogenic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021814-43 Sponsor Protocol Number: 5703433 Start Date*: 2011-05-17
    Sponsor Name:Ulrich Tacke
    Full Title: The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
    Medical condition: Patients with opioid addiction.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10030900 Opium addiction LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-007815-99 Sponsor Protocol Number: AN07/8429 Start Date*: 2009-03-09
    Sponsor Name:Leeds Teaching Hospitals NHS Trust
    Full Title: The optimal dose of subcutaneous naloxone for the treatment of intrathecal opioid- induced pruritus following elective caesarean section delivery
    Medical condition: Pruritus secondary to intrathecal opioids
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049981 Drug-induced pruritus LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003107-65 Sponsor Protocol Number: OPNT001-BN-001 Start Date*: 2017-01-11
    Sponsor Name:Opiant Pharmaceuticals Inc
    Full Title: Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa
    Medical condition: Bulimia nervosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10006550 Bulimia nervosa PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-001356-20 Sponsor Protocol Number: 0602001 Start Date*: 2006-06-05
    Sponsor Name:Reckitt Benckiser (UK) Limited
    Full Title: A preliminary single dose, three-way, double-blind, placebo-controlled crossover study of intravenous buprenorphine/naloxone in the treatment of neuropathic pain of diabetic neuropathy origin.
    Medical condition: Neuropathic pain
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003504-22 Sponsor Protocol Number: UCDCRC/015/006 Start Date*: 2015-10-09
    Sponsor Name:UCD
    Full Title: The NAPRESSIM trial. The use of low dose prophylactic naloxone infusion to prevent respiratory depression with intrathecal morphine.
    Medical condition: Respiratory Depression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038678 Respiratory depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005903-34 Sponsor Protocol Number: KKSMUW2011-09 Start Date*: 2012-05-04
    Sponsor Name:G. L. Pharma GmbH
    Full Title: Phase II, single centre, double blinded, cross-over dose confirmation study using two morphine-naloxone i.v. solutions
    Medical condition: Treatment of opioid dependence
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002229-23 Sponsor Protocol Number: RB-UK-11-0018 Start Date*: 2012-05-09
    Sponsor Name:RB Pharmaceuticals Inc.
    Full Title: A randomised, double blind, placebo controlled, cross over study of the effects of Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate intravenous challenges in opioid dependen...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002310-72 Sponsor Protocol Number: 0201/DEV Start Date*: 2016-03-29
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Open-label, uncontrolled trial to evaluate pharmacokinetics of naloxone in children from 4 to less than 18 years of age with opioid-induced constipation
    Medical condition: Opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Temporarily Halted) HU (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2017-001946-93 Sponsor Protocol Number: NalGamb Start Date*: 2017-10-31
    Sponsor Name:National Instute of Health and Welfare
    Full Title: Double-blind, placebo-controlled randomised study on the efficacy of naloxone nasal spray for the treatment of gambling disorder
    Medical condition: Problem gambling
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000167845 10017657 Gambling pathological LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-000657-39 Sponsor Protocol Number: 0217/DEV Start Date*: 2017-08-15
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Randomised, double-blind, placebo-controlled, parallel-group, multi-centre, phase III trial to investigate the efficacy, safety and tolerability of Naloxone HCl PR Tablets in patients with opioid i...
    Medical condition: Opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) SK (Completed) ES (Completed) BG (Completed) PT (Completed) GB (Completed) HU (Prematurely Ended)
    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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