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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 2 of 5.
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    EudraCT Number: 2016-002623-29 Sponsor Protocol Number: Lundbeckstudy2016 Start Date*: 2016-08-29
    Sponsor Name:Aalborg Universitets Hospital
    Full Title: The Effect of Morphine on the Human Central Nervous System
    Medical condition: Healthy volunteers (Brain response to i.v. morphine)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DK (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: 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: 2013-004888-31 Sponsor Protocol Number: OXN3508 Start Date*: 2015-01-26
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, cross-over multicenter study to demonstrate equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as ...
    Medical condition: The intended indication is: Chronic severe non malignant pain, chronic severe malignant pain, requiring opioids.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-010360-41 Sponsor Protocol Number: BU0902 Start Date*: 2009-06-03
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France
    Medical condition: For both compounds, substitution treatment for opioid drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intra...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012346 Dependence on opiates LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-001313-42 Sponsor Protocol Number: OXN2001 (Inc. Amd 3) Start Date*: 2007-11-02
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to...
    Medical condition: subjects with moderate to severe, chronic cancer pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    9.1 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DE (Completed) HU (Completed) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003003-30 Sponsor Protocol Number: 2014-853 Start Date*: 2014-10-31
    Sponsor Name:HOSPICES CIVILS DE LYON
    Full Title: ENALEPSIE EFFICACY OF NALOXONE IN REDUCING POSTICTAL CENTRAL RESPIRATORY DYSFUNCTION IN PATIENTS WITH EPILEPSY.
    Medical condition: Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with drug-resistant epilepsy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10065336 Partial epilepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003409-86 Sponsor Protocol Number: Methnalox2012 Start Date*: 2012-10-09
    Sponsor Name:KULeuven
    Full Title: The effect of naloxone and methylnaltrexone on oesophageal sensitivity in healthy volunteers: a randomized, double-blind placebo controlled study.
    Medical condition: Altered oesophageal sensitivity
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017193-20 Sponsor Protocol Number: S51994 Start Date*: 2010-01-28
    Sponsor Name:UZLeuven
    Full Title: Effect of naloxone and methylnaltrexone on satiety, gastric sensitivity, and accommodation to food in healthy volunteers.
    Medical condition: healthy volunteers none; this is a physiological study to investigate the influence of opioid antagonism on gastric sensorimotor function
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000329-22 Sponsor Protocol Number: 0602004 Start Date*: 2007-09-20
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A randomised, double blind, crossover pilot study of intravenous buprenorphine versus intravenous buprenorphine/ naloxone in patients with chronic pain.
    Medical condition: Chronic pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-001026-14 Sponsor Protocol Number: OXN3501 Start Date*: 2009-05-19
    Sponsor Name:Mundipharma Pharmaceuticals BV [...]
    1. Mundipharma Pharmaceuticals BV
    2. Mundipharma Comm VA
    Full Title: An open study with OXN to evaluate the patient preference for pain treatment with respect to quality of life after WHO step I or step II analgesics for patients with moderate to severe non-malignan...
    Medical condition: moderate to severe pain non-malignant pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033371 Pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012814-36 Sponsor Protocol Number: HDL09-01 Start Date*: 2009-09-23
    Sponsor Name:Helsingin Diakonissalaitos
    Full Title: Buprenorfiini-naloksoni ja metadoni erilaisissa psykososiaalisissa hoito-ohjelmissa buprenorfiiniriippuvaisten korvaushoidossa. Satunnaistettu kontrolloitu tutkimus
    Medical condition: Opioidiriippuvuus, buptenorfiinin suonensisäinen väärinkäyttö
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030893 Opioid type dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-003925-23 Sponsor Protocol Number: PIANISSIMO Start Date*: 2023-04-12
    Sponsor Name:Vrije Universiteit Brussel
    Full Title: Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation.
    Medical condition: Persistent spinal pain syndrome type 2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-011853-42 Sponsor Protocol Number: NALCOL 01 Start Date*: 2009-12-22
    Sponsor Name:Norfolk and Norwich University Hospital NHS Trust
    Full Title: NALOXONE HYDROCHLORIDE SR GASTRO-RESISTANT SUSTAINED RELEASE CAPSULES AS A TREATMENT FOR FUNCTIONAL CONSTIPATION: A RANDOMISED, DOUBLE BLIND CONTROLLED TRIAL IN SECONDARY CARE
    Medical condition: Functional constipation
    Disease: Version SOC Term Classification Code Term Level
    11 10010774 Constipation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004709-17 Sponsor Protocol Number: MP_SM01_2013 Start Date*: 2014-02-10
    Sponsor Name:Rigshospitalet
    Full Title: Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Inguinal Post-herniotomy Patients – A Randomized, Placebo-controlled, Double-blind Study
    Medical condition: First degree burn injury in healthy volunteers who 6-8 weeks prior have had done a Inguinal herniotomy .
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-018118-21 Sponsor Protocol Number: OXN2503 Start Date*: Information not available in EudraCT
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to place...
    Medical condition: Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004857 10008927 Chronic interstitial cystitis LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002398-57 Sponsor Protocol Number: OXN3001 Start Date*: 2005-11-23
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomized, double-blind, parallel-group, multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of >= 20 mg/day ...
    Medical condition: Moderate to severe non-malignant pain that requires around the clock opioid therapy and also have constipation secondary to opioid treatment.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016079-32 Sponsor Protocol Number: AS Start Date*: 2010-12-02
    Sponsor Name:Universitätsklinik für Psychiatrie - Spezialambulanz für Abhangigkeitserkrankungen
    Full Title: Auswirkungen der Substitutionstherapie mit Methadon und Buprenorphin auf die kognitiven Funktionen.
    Medical condition: Untersuchung der kognitiven Leistungsfähigkeit bei Opiatabhängigen, die sich in der Substitutionstherapie unter Methadon und unter Buprenorphin befinden.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    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: 2014-005521-12 Sponsor Protocol Number: OX-NAL14 Start Date*: 2015-10-26
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: MANAGMENT OF PATIENT WITH MODERATE TO SEVERE POSTOPERATIVE PAIN AFTER SURGERY FOR HYSTERECTOMY: BLIND, RANDOMZATED, CONTROLLATED EXPERIMENTAL STUDY ON THE CONTROL OF PAIN SYNTOMS AND SIDE EFFECTS T...
    Medical condition: POSTOPERATIVE PAIN AFTER HYSTERECTOMY
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10054711 Postoperative pain LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (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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