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Clinical trials for Prucalopride

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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    19 result(s) found for: Prucalopride. Displaying page 1 of 1.
    EudraCT Number: 2017-004175-31 Sponsor Protocol Number: Prucalopride2017 Start Date*: 2018-04-09
    Sponsor Name:TARGID, KU Leuven
    Full Title: A placebo-controlled trial with prucalopride for the treatment of typical reflux symptoms in patients with gastro-esophageal reflux disease with incomplete proton pump inhibitor response
    Medical condition: refractory gastro-esophageal reflux disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004367-44 Sponsor Protocol Number: picopru Start Date*: 2013-05-28
    Sponsor Name:KU LEUVEN
    Full Title: A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO COMPARE THE EFFECT OF SODIUM PICOSULFATE AND PRUCALOPRIDE ON COLONIC SENSORY AND MOTOR RESPONSE TO DISTENSION IN HEALTHY SUBJECTS
    Medical condition: SENSORY AND MOTOR RESPONSE OF DESCENDING COLON TO DISTENSION WILL BE STUDIED IN HEALTHY SUBJECTS
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000821-30 Sponsor Protocol Number: SAD13-ER1 Start Date*: 2013-07-12
    Sponsor Name:Enrique Rey Díaz-Rubio
    Full Title: CLINICAL RESPONSE TO 5HT4 RECEPTORS AGONIST (PRUCALOPRIDE): GASTROCOLIC REFLEX
    Medical condition: chronic constipation
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002705-65 Sponsor Protocol Number: PrucaloprideGastro1 Start Date*: 2013-09-26
    Sponsor Name:TARGID
    Full Title: The effect of Prucalopride (Resolor) on gastric motor function and gastric sensitivity
    Medical condition: Functional dyspepsia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023996-25 Sponsor Protocol Number: 26081985 Start Date*: 2010-12-21
    Sponsor Name:
    Full Title: The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis.
    Medical condition: Multiple sclerosis (both relapsing remitting and progressive forms)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022402-40 Sponsor Protocol Number: M0001-C303 Start Date*: 2011-05-05
    Sponsor Name:Shire-Movetis NV
    Full Title: Trial consisting of an 8-week double-blind placebo-controlled part to evaluate efficacy, safety, tolerability and pharmacokinetics of prucalopride in paediatric subjects with functional constipatio...
    Medical condition: Functional constipation in paediatric subjects
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) FR (Completed) GB (Completed) DE (Completed) HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015652-20 Sponsor Protocol Number: M0001-C301/SPD555-301 Start Date*: 2010-05-10
    Sponsor Name:Shire-Movetis NV
    Full Title: A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation
    Medical condition: opioid induced constipation in subjects with chronic non-cancer pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) PL (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) FR (Completed) NL (Prematurely Ended) BG (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-003221-22 Sponsor Protocol Number: TAK-555-3010 Start Date*: 2024-01-15
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting o...
    Medical condition: Constipation
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000670-62 Sponsor Protocol Number: M0001-C401(SPD555-C401) Start Date*: 2011-05-26
    Sponsor Name:Shire-Movetis NV
    Full Title: A randomised, double-blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of long-term treatment (24 weeks) with prucalopride in subjects aged ≥18 year...
    Medical condition: Chronic constipation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) HU (Completed) SE (Completed) IT (Completed) ES (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-015719-42 Sponsor Protocol Number: M0001-C302 Start Date*: 2010-08-12
    Sponsor Name:Shire-Movetis NV
    Full Title: A 12-week, randomised, double-blind, placebo controlled trial to evaluate the efficacy, quality of life, safety and tolerability of prucalopride in male subjects with chronic constipation
    Medical condition: Chronic constipation
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10063582 Constipation chronic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) GB (Completed) FR (Completed) NL (Completed) BG (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-000308-16 Sponsor Protocol Number: prucalopride1 Start Date*: 2011-10-24
    Sponsor Name:UZ Leuven
    Full Title: Prucalopride versus Placebo in Idiopathic and Diabetic Gastroparesis
    Medical condition: Patients with delayed gastric emptying (t1/2 for solids ≥ 109 min) either from idiopathic or diabetic origin
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10021227 Idiopathic gastroparesis LLT
    14.0 10017947 - Gastrointestinal disorders 10051153 Diabetic gastroparesis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002192-18 Sponsor Protocol Number: PrucaloprideRNAseq Start Date*: 2018-09-14
    Sponsor Name:KU Leuven
    Full Title: Characterization of nerve-modulated macrophage population in the gastrointestinal tract
    Medical condition: Patients undergoing colorectal surgery due to benign or malignant carcinoma, diverticulitis or constipation drug will be used to differentiate between macrophages that are modulated by enteric neu...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002495-13 Sponsor Protocol Number: SPD555-403 Start Date*: 2013-01-14
    Sponsor Name:Shire-Movetis NV
    Full Title: An Open-label, Randomized, Crossover, Reader-blinded Study To Investigate the Effect of Prucalopride and Polyethylene Glycol 3350 on Colon Motility with Intraluminal Manometry in Subjects with C...
    Medical condition: Chronic Constipation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004174-34 Sponsor Protocol Number: Citalopram2017 Start Date*: 2018-04-10
    Sponsor Name:Targid, KU Leuven
    Full Title: A placebo-controlled trial with citalopram for the treatment of typical reflux symptoms in patients with reflux hypersensitivity or functional heartburn with incomplete proton pump inhibitor response
    Medical condition: Functional heartburn and reflux hypersensitivity with incomplete respons to proton pomp inhibitors
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000361-52 Sponsor Protocol Number: prucalopride/VNS1 Start Date*: 2014-05-15
    Sponsor Name:KULeuven
    Full Title: Pilot study: Anti-inflammatory effect of preoperative stimulation of the enteric nervous system: a potential new therapeutic intervention to shorten gastroparesis
    Medical condition: Patients undergoing pancreaduodenectomy due to benign or malignant tumor drug will be studied for prokinetic or anti-inflammatory effects, because they are known to influence gastrointestinal mo...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005348-92 Sponsor Protocol Number: PROGASS Start Date*: 2013-02-19
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis
    Medical condition: Sysemic sclerosis with gastroenteric involvement (constipation)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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
    EudraCT Number: 2014-003250-13 Sponsor Protocol Number: 0099 Start Date*: 2015-05-06
    Sponsor Name:Theravance Biopharma R&D, Inc.
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic ...
    Medical condition: diabetic or idiopathic gastroparesis.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10017947 - Gastrointestinal disorders 10021227 Idiopathic gastroparesis LLT
    17.1 10017947 - Gastrointestinal disorders 10051153 Diabetic gastroparesis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (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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