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Clinical trials for Nalbuphine

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   44335   clinical trials with a EudraCT protocol, of which   7366   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.
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    7 result(s) found for: Nalbuphine. Displaying page 1 of 1.
    EudraCT Number: 2013-005626-29 Sponsor Protocol Number: TR02ext Start Date*: 2015-01-21
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER Tablets in Hemodialysis Patients with Uremic Pruritus
    Medical condition: Uremic Pruritis in Hemodialysis Patients
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-004744-31 Sponsor Protocol Number: TR12 Start Date*: 2019-06-24
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment ...
    Medical condition: Treatment of Cough in Idiopathic Pulmonary Fibrosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-005628-41 Sponsor Protocol Number: TR03ext Start Date*: 2015-02-06
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER Tablets in Prurigo Nodularis Patients
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005625-22 Sponsor Protocol Number: TR02 Start Date*: 2015-01-12
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritis
    Medical condition: Uremic Pruritis in Hemodialysis Patients
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-001219-53 Sponsor Protocol Number: TR11 Start Date*: 2019-03-06
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRI...
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10037084 Prurigo nodularis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022351-28 Sponsor Protocol Number: 2010/38 Start Date*: 2010-11-03
    Sponsor Name:Hôpital FOCH
    Full Title: Essai prospectif randomisé, en double aveugle, comparant la Nalbuphine à l'association Hydroxyzine-Salbutamol dans la dystocie de démarrage.
    Medical condition: Dystocie de Démarrage
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-005627-17 Sponsor Protocol Number: TR03 Start Date*: 2015-12-01
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER Tablets in Prurigo Nodularis Patients
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) AT (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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