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Clinical trials for Lubiprostone

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   44336   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 ).  
     
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    5 result(s) found for: Lubiprostone. Displaying page 1 of 1.
    EudraCT Number: 2013-004384-31 Sponsor Protocol Number: SAG/0211PFC-11S1 Start Date*: 2015-06-10
    Sponsor Name:Sucampo AG
    Full Title: A Multicentre, Long-term Safety, Efficacy and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥6 to <18 years with Functional Constipation
    Medical condition: functional constipation in paediatric patients
    Disease: Version SOC Term Classification Code Term Level
    16.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) ES (Ongoing) NL (Completed) FR (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003468-30 Sponsor Protocol Number: SAG/0211PFC-1131 Start Date*: 2014-09-24
    Sponsor Name:Sucampo Pharma Europe Ltd.
    Full Title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional...
    Medical condition: functional constipation in paediatric patients
    Disease: Version SOC Term Classification Code Term Level
    18.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) ES (Prematurely Ended) NL (Completed) PL (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-022991-29 Sponsor Protocol Number: SMR/0211OBD-1033 Start Date*: 2011-02-01
    Sponsor Name:Sucampo Pharma Americas, Inc.
    Full Title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Patients with Opioid-induced Bowel Dysfunction
    Medical condition: Opioid-induced Bowel Dysfunction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10061247 Intestinal functional disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-005587-94 Sponsor Protocol Number: 000079 Start Date*: 2013-05-12
    Sponsor Name:Ferring International Pharmascience Center US, Inc.
    Full Title: A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks
    Medical condition: Chronic idiopathic constipation
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10072118 Chronic idiopathic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended) CZ (Prematurely Ended) GB (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005588-28 Sponsor Protocol Number: 000080 Start Date*: 2013-06-04
    Sponsor Name:Ferring International Pharmascience Center US, Inc.
    Full Title: A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 12 Weeks Follo...
    Medical condition: Chronic idiopathic constipation
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004856 10072118 Chronic idiopathic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Completed) SK (Completed) HU (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended) PL (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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