Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Naloxegol

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   44338   clinical trials with a EudraCT protocol, of which   7368   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    6 result(s) found for: Naloxegol. Displaying page 1 of 1.
    EudraCT Number: 2013-003935-32 Sponsor Protocol Number: D3820C00016 Start Date*: 2014-03-07
    Sponsor Name:Kyowa Kirin Pharmaceutical Development Ltd.
    Full Title: A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment with Opioids
    Medical condition: Opioid-induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Prematurely Ended) NO (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000087-26 Sponsor Protocol Number: 2019/09 Start Date*: 2020-04-16
    Sponsor Name:CMC AMBROISE PARE
    Full Title: Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial
    Medical condition: ileus after cardiac surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004863 10017501 Functional disturbances following cardiac surgery LLT
    20.1 100000004863 10051798 Postoperative constipation LLT
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000419-42 Sponsor Protocol Number: Nalogexol-2014 Start Date*: 2015-05-11
    Sponsor Name:Aalborg University Hospital
    Full Title: Naloxegol and assessments of opioid induced bowel dysfunction
    Medical condition: Healthy volunteers (Opioid-induced bowel dysfunction)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (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: 2020-003687-10 Sponsor Protocol Number: NALUGStrial Start Date*: 2022-01-26
    Sponsor Name:UZLeuven
    Full Title: Naloxegol for improving upper gastrointestinal symptoms and gastric emptying rate in patients with opioid induced constipation
    Medical condition: Opioid induced gastrointestinal dysfunction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10013225 Disorder gastrointestinal LLT
    20.1 100000004873 10079385 Opioid use disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000959-14 Sponsor Protocol Number: 29BRC18.0262 Start Date*: 2021-03-16
    Sponsor Name:CHRU de Brest
    Full Title: The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.
    Medical condition: Prevent opioids induced gastrointestinal motility disturbance in brain Injured Patients.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10061173 Gastrointestinal motility disorder PT
    21.1 10029205 - Nervous system disorders 10042316 Subarachnoid haemorrhage PT
    20.0 100000004863 10078809 Skull trauma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 23 18:16:45 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA