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Clinical trials for Linaclotide

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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    9 result(s) found for: Linaclotide. Displaying page 1 of 1.
    EudraCT Number: 2013-004939-73 Sponsor Protocol Number: LINACLOTIDEPLACEBO Start Date*: 2014-05-13
    Sponsor Name:KULEUVEN
    Full Title: A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY ASSESSED WITH INTRALUMINAL COLONIC MANOMETRY IN HEALTHY SUBJECTS
    Medical condition: COLONIC MOTILITY WILL BE STUDIED IN HEALTHY SUBJECTS
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001955-38 Sponsor Protocol Number: LIN-MD-66 Start Date*: 2021-05-10
    Sponsor Name:Allergan Ltd
    Full Title: A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C)
    Medical condition: Functional Constipation (FC) Irritable bowel syndrome with constipation (IBS-C)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    20.1 10017947 - Gastrointestinal disorders 10066868 Constipation predominant irritable bowel syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002017-28 Sponsor Protocol Number: LinaclotideRectumColon Start Date*: 2014-07-16
    Sponsor Name:KULEUVEN
    Full Title: ROLE OF THE TYPE AND SITE OF DISTENSION IN THE EVALUATION OF DRUGS EFFICACY IN MODULATING THE SENSORY AND MOTOR RESPONSE OF THE DESCENDING COLON AND THE RECTUM IN MAN
    Medical condition: HEALTHY SUBJECTS AND PATIENTS WITH IRRITABLE BOWEL SYNDROME
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001500-38 Sponsor Protocol Number: LIN-MD-64-EU-3 Start Date*: 2020-06-15
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional C...
    Medical condition: Functional Constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) EE (Completed) DE (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002126-75 Sponsor Protocol Number: LIN-MD-67 Start Date*: 2021-10-13
    Sponsor Name:Allergan
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) with ...
    Medical condition: Functional Constipation (FC)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001248-67 Sponsor Protocol Number: LIN4113 Start Date*: 2014-01-14
    Sponsor Name:almirall
    Full Title: CLINICAL TRIAL PHASE IIIb to evaluate predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms
    Medical condition: Irritable bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000818-29 Sponsor Protocol Number: MCP-103-403 Start Date*: 2016-08-08
    Sponsor Name:Ironwood Pharmaceuticals, Inc.
    Full Title: A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants with Irritable Bowel Syndrom...
    Medical condition: Irritable Bowel Syndrome with Constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10066868 Constipation predominant irritable bowel syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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