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Clinical trials for Constipation in children

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   44363   clinical trials with a EudraCT protocol, of which   7387   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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    26 result(s) found for: Constipation in children. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-005961-77 Sponsor Protocol Number: 3200K1-3357-WW Start Date*: 2009-05-06
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation Estudio multicéntrico, aleatorizado, en do...
    Medical condition: Opioid-induced constipation in subjects with non-malignant pain Tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010774 Constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-005935-14 Sponsor Protocol Number: 3200K1-3358-WW Start Date*: 2009-04-24
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: An Open-Label Study to Evaluate the Long-term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain Estudio abierto para evaluar la segurida...
    Medical condition: Opioid-induced constipation in subjects with non-malignant pain Tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010774 Constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    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: 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: 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: 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: 2008-005692-10 Sponsor Protocol Number: 3200K1-4006-WW Start Date*: 2009-03-25
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Randomized, Double-blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Rel...
    Medical condition: Opioid-induced constipation in subjects with cancer-related pain Estreñimiento inducido por opiáceos en pacientes con dolor de origen tumoral
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004354-28 Sponsor Protocol Number: S-20120017 Start Date*: 2013-07-02
    Sponsor Name:Børneafdelingen Kolding
    Full Title: Maintenance treatment in childhood constipation. A randomized placebo-controlled intervention study
    Medical condition: Childhood functional constipation.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023538-22 Sponsor Protocol Number: LY107 Start Date*: 2011-08-30
    Sponsor Name:Lipid Pharmaceuticals
    Full Title: Lýsi sem hægðalyf fyrir börn
    Medical condition: The primary objective of this trial is to investigate the laxative effect of Lysisstílar (Free Fatty Acids suppositories) as compared to Klyx. Participants are children aged 1 year old to 17 year...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IS (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005111-32 Sponsor Protocol Number: ABO-MELI-15 Start Date*: 2016-02-24
    Sponsor Name:ABOCA S.P.A. SOCIETà AGRICOLA
    Full Title: Multicenter, Prospective, Comparative, Randomized Controlled Clinical investigation on the performance of Promelaxin® micro-enemas versus oral administration of Macrogol 4000, in the treatment of c...
    Medical condition: Chronic Functional Constipation
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10067374 Stypsis LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (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: 2015-002310-72 Sponsor Protocol Number: 0201/DEV Start Date*: 2016-03-29
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Open-label, uncontrolled trial to evaluate pharmacokinetics of naloxone in children from 4 to less than 18 years of age with opioid-induced constipation
    Medical condition: Opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Temporarily Halted) HU (Prematurely Ended) CZ (Completed)
    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: 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: 2013-003935-32 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: 2015-003293-32 Sponsor Protocol Number: Duski2015 Start Date*: 2017-11-06
    Sponsor Name:Academic Medical Center
    Full Title: Multicentre, Randomised, Placebo-Controlled Trial of Mebeverine in Children with Irritable Bowel Syndrome (IBS) or Functional Abdominal Pain - not otherwise specified (FAP-NOS)
    Medical condition: Functional Gastrointestinal Disorders (Irritable Bowel Syndrome or Functional Abdominal Pain - not otherwise specified)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10064907 Functional abdominal pain LLT
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004360-22 Sponsor Protocol Number: KF5503-66 Start Date*: 2014-10-02
    Sponsor Name:Grünenthal GmbH
    Full Title: An open label trial, enrolling subjects aged 6 years to less than 18 years suffering from pain requiring prolonged release opioid treatment, to evaluate the safety and efficacy of tapentadol PR ver...
    Medical condition: Pain requiring prolonged release opioid treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000023314 10049475 Chronic pain LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PT (Completed) ES (Completed) SK (Prematurely Ended) BE (Completed) IT (Completed) SI (Prematurely Ended) HU (Completed) BG (Completed) HR (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005467-32 Sponsor Protocol Number: n.a. Start Date*: 2016-08-08
    Sponsor Name:Haga Teaching Hospital
    Full Title: A randomised controlled trial on the effect of laxative therapy in children with functional abdominal pain
    Medical condition: Functional abdominal pain
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004519-31 Sponsor Protocol Number: ENTERL08784 Start Date*: 2019-01-31
    Sponsor Name:Sanofi
    Full Title: Randomized, placebo-controlled, clinical trial to evaluate the efficacy of probiotic Bacillus clausii in the treatment of pediatric patients with irritable bowel syndrome
    Medical condition: Irritable bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005452-41 Sponsor Protocol Number: DPM-B-301 Start Date*: 2006-05-26
    Sponsor Name:Pharmaxis UK Limited
    Full Title: A phase III Multicenter, randomised, parallel, placebo-controlled, double-blind study to investigate the safety and efficacy of treatment with Bronchitol (dry powder mannitol) in the symptomatic tr...
    Medical condition: Bronchiectasis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (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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