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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
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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   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 3 of 5.
    « Previous 1  2  3  4  5  Next»
    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: 2011-005060-26 Sponsor Protocol Number: ONU3704 Start Date*: 2012-06-19
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Eff...
    Medical condition: Opioid-induced Constipation & Moderate to Severe Chronic Low back Pain
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10003988 Back pain PT
    17.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-006686-17 Sponsor Protocol Number: P05094 Start Date*: 2007-04-25
    Sponsor Name:Schering-Plough
    Full Title: Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent...
    Medical condition: For both compounds, substitution treatment for opiod drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intrav...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-001772-11 Sponsor Protocol Number: OXN2505 Start Date*: 2014-01-23
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: An exploratory, double-blind, double-dummy, randomised, 2-period, crossover, Phase IIa study to assess the influence of oxycodone/naloxone prolonged-release tablets (OXN PR) and oxycodone prolonged...
    Medical condition: The intended indication is: Chronic severe non malignant pain, requiring opioids.
    Disease: Version SOC Term Classification Code Term Level
    16.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-002670-36 Sponsor Protocol Number: OXN3503 Start Date*: 2009-01-30
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with...
    Medical condition: Pain, locomotor function and improvement in constipation in osteoarthritis patients taking opioids
    Disease: Version SOC Term Classification Code Term Level
    9.1 10031161 Osteoarthritis LLT
    9.1 10021175 Iatrogenic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed) NL (Completed) ES (Completed) AT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002408-42 Sponsor Protocol Number: RB-UK-12-0004 Start Date*: 2012-11-29
    Sponsor Name:Reckitt Benckiser Pharmaceuticals Inc.
    Full Title: An Open-label, Randomised, Three -Way, Cross-Over Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Formulations of RBP-6300 10mg in Healthy Volunteers under a Naltrexone Block i...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000808-32 Sponsor Protocol Number: 1.5 Start Date*: 2007-09-19
    Sponsor Name:Leiden University Medical Center
    Full Title: A comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor
    Medical condition: laborpain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052803 Analgesic effect LLT
    Population Age: Adults Gender:
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012658-19 Sponsor Protocol Number: Protocol_KET-MET_2009 Start Date*: 2009-08-27
    Sponsor Name:Leiden University Medical Center
    Full Title:
    Medical condition: Acute pain to be tested in healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011107-23 Sponsor Protocol Number: OXN3502 Start Date*: Information not available in EudraCT
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime sympt...
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005061-20 Sponsor Protocol Number: ONU3705 Start Date*: 2012-06-19
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Eff...
    Medical condition: Opioid-induced Constipation & Moderate to Severe Chronic Low back Pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10071128 Opioid induced constipation LLT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10003988 Back pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) SK (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-002426-10 Sponsor Protocol Number: OXN4502 Start Date*: 2008-12-19
    Sponsor Name:Napp Pharmaceuticals Ltd
    Full Title: A double-blind, double-dummy, parallel group, randomised study to compare the efficacy and tolerability of oxycodone/naloxone prolonged release (OXN PR) and codeine/paracetamol in the treatment of...
    Medical condition: Moderate to severe chronic lowback pain or pain due to osteoarthritis of the hip and/or knee.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-002901-31 Sponsor Protocol Number: OXN2504 Start Date*: 2011-11-25
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain
    Medical condition: Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) CZ (Completed) HU (Completed)
    Trial results: View results
    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: View results
    EudraCT Number: 2008-005815-17 Sponsor Protocol Number: OXN2502 Start Date*: 2009-06-09
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: An exploratory, randomised, double-blind, single-dummy, placebo controlled, parallel group study to demonstrate the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) in ad...
    Medical condition: Severe pain due to diabetic polyneuropathy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012685 Diabetic polyneuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2004-003752-19 Sponsor Protocol Number: OXN3401 Start Date*: 2005-02-01
    Sponsor Name:Mundipharma Research GmbH & Co.KG
    Full Title: A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with ...
    Medical condition: Moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003988 pt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DK (Completed) SK (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021995-27 Sponsor Protocol Number: OXN3506 Start Date*: 2011-07-13
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation and non-inferiority in analgesic efficacy in subjects with non-mali...
    Medical condition: The intended indication is: Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocki...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    16.1 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DE (Completed) FI (Completed) DK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-004775-36 Sponsor Protocol Number: DETOX-11 Start Date*: 2012-01-30
    Sponsor Name:GET SRL
    Full Title: ''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms d...
    Medical condition: Oppiate addicts(heroin, methadone and buprenorphine)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10032707 Other specified drug dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003302-25 Sponsor Protocol Number: PRG-OXYCODONE-06/01 Start Date*: 2006-11-30
    Sponsor Name:Barts and The London NHS Trust
    Full Title: A prospective, randomised, double-blind, placebo-controlled trial to assess the respiratory effects of oxycodone versus morphine in anaesthetised patients
    Medical condition: Patients scheduled to undergo surgery of more than 30 minutes duration under general anaesthesia will be recruited. We are not investigating a medical disease.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015943-17 Sponsor Protocol Number: ONCO_PAIN01/2009 Start Date*: 2010-04-23
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: SEQUENTIAL STUDY ON THE INCIDENCE AND INTENSITY OF INTESTINAL CONSTIPATION ASSOCIATED TO OXYCODONE (OXYCONTIN) AND THE COMBINATION OF OXYCODONE/NALOXONE (TARGIN) FOR CHRONIC ONCOLOGIC PAIN TREATMEN...
    Medical condition: Advanced neoplastic desease with pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045171 LLT
    9.1 10010774 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003510-15 Sponsor Protocol Number: OXN3006 (incl. Admin. Change 1) Start Date*: 2006-03-06
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of ...
    Medical condition: Moderate to severe chronic 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
    7.1 10003988 pt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) ES (Completed) CZ (Completed) HU (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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