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Clinical trials for Budesonide

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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    357 result(s) found for: Budesonide. Displaying page 1 of 18.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2019-003271-19 Sponsor Protocol Number: DDD19IBDBUD Start Date*: 2019-12-20
    Sponsor Name:KU Leuven
    Full Title: Intestinal disposition of budesonide in healthy volunteers
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003362-41 Sponsor Protocol Number: BUS-2/UCA Start Date*: 2013-07-24
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomized, double-blind, multicentre study to compare the efficacy and safety of two different dosages of a novel budesonide suppository versus a mesalazine suppository versus a combination therap...
    Medical condition: Acute ulcerative proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016692-29 Sponsor Protocol Number: BUU-2/EEA Start Date*: 2012-02-20
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomized, placebo-controlled, phase IIa study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspen...
    Medical condition: Active eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10064220 Eosinophilic esophagitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001921-15 Sponsor Protocol Number: BUS-4/UCA Start Date*: 2017-03-09
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, double-dummy, multicentre study to compare the efficacy and safety of once daily novel 4 mg budesonide suppository versus once daily 2 mg budesonide foam in patients with ...
    Medical condition: Acute Ulcerative Proctitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045368 Ulcerative proctitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) HU (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002465-30 Sponsor Protocol Number: EE-01bude2014 Start Date*: Information not available in EudraCT
    Sponsor Name:Dip. Pediatria UOC Gastroenterologia ed Epatologia Pediatrica
    Full Title: Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.
    Medical condition: Eosinophilic Esophagitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-002214-35 Sponsor Protocol Number: BY9010/CP-038 Start Date*: 2006-08-01
    Sponsor Name:ALTANA Pharma AG
    Full Title: Free, not protein-bound concentrations of budesonide in subcutaneous adipose tissue, muscle tissue, and serum after oral inhalation via Turbohaler®
    Medical condition: Phase I healthy volunteer study
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002593-27 Sponsor Protocol Number: S64291 Start Date*: 2022-06-17
    Sponsor Name:UZ Leuven
    Full Title: Budesonide as a treatment for low-grade duodenal inflammation in functional dyspepsia.
    Medical condition: Functional dyspepsia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004576-57 Sponsor Protocol Number: BUX-4/UCA Start Date*: 2019-04-26
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsul...
    Medical condition: Patients with active ulcerative colitis refractory to standard treatment with mesalazine
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) HU (Completed) SK (Completed) LT (Prematurely Ended) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003330-91 Sponsor Protocol Number: BUSAL-II-17-1 Start Date*: 2017-11-29
    Sponsor Name:Laboratoires SMB S.A.
    Full Title: A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salme...
    Medical condition: Regular Treatment of Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000015470 10003560 Asthma NOS LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-003737-29 Sponsor Protocol Number: BUU-5/EEA Start Date*: Information not available in EudraCT
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophi...
    Medical condition: Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10064220 Eosinophilic esophagitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PT (Completed) NL (Completed) GR (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-006957-42 Sponsor Protocol Number: BUG-2/CDA Start Date*: 2009-10-30
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide th...
    Medical condition: Induction of remission in active Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10058815 Crohn's disease acute episode LLT
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) LT (Completed) BG (Completed) CZ (Completed) LV (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2017-003516-39 Sponsor Protocol Number: BUL-3/EER Start Date*: 2021-04-28
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment...
    Medical condition: Maintenance of remission in eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10064220 Eosinophilic esophagitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001667-85 Sponsor Protocol Number: MDL_2020_10 Start Date*: 2020-05-15
    Sponsor Name:Hôpital Fondation Adolphe de Rothschild
    Full Title: A randomized controlled trial evaluating the efficacy of local budesonide therapy in the management of hyposmia in COVID-19 patients without signs of severity
    Medical condition: Patients with persistent hyposmia related to a SARS-CoV-2 infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004035-30 Sponsor Protocol Number: VPI-102-03 Start Date*: 2006-11-07
    Sponsor Name:Verus Pharmaceuticals Inc
    Full Title: A Randomised, Single Dose Exposure Study to Assess the Safety, Tolerability and Pharmacokinetics of Investigational Captisol-Enabled® Budesonide Inhalation Solution (CBIS) Delivered via eFlow® Nebu...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002691-14 Sponsor Protocol Number: RC2019.1.6_ROSSI Start Date*: 2019-10-30
    Sponsor Name:IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    Full Title: VISCOUS BUDESONIDE IN PATIENTS AFFECTED BY EOSINOPHILIC ESOPHAGITIS, OPERATED FOR ESOPHAGEAL ATRESIA
    Medical condition: Eosinophilicesophagitis (EoE) in Esophageal atresia (EA).
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10064212 Eosinophilic oesophagitis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002523-17 Sponsor Protocol Number: D589OC00003 Start Date*: 2011-09-05
    Sponsor Name:AstraZeneca AB
    Full Title: A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy, Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered D...
    Medical condition: Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-012805-20 Sponsor Protocol Number: D5890L00032 Start Date*: 2009-06-29
    Sponsor Name:AstraZeneca AB
    Full Title: A randomised, double blind, placebo controlled, parallel-group study with use of budesonide/formoterol “as-needed”, or terbutaline “as-needed” or regular use of budesonide + terbutaline “as-needed”...
    Medical condition: Exercise induced bronchoconstriction
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015649 Exercise induced asthma LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003013-41 Sponsor Protocol Number: BKR-KNAST-06 Start Date*: 2006-07-13
    Sponsor Name:Children's Clinic Randers
    Full Title: Short-term and longterm growth in children with asthma treated with budesonide or montelukast
    Medical condition: asthma
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001314-37 Sponsor Protocol Number: BUL-8/EEA Start Date*: 2021-04-26
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets fo...
    Medical condition: eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10064212 Eosinophilic oesophagitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001912-31 Sponsor Protocol Number: BUG-3/MIC Start Date*: 2014-02-19
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis
    Medical condition: Patients with active incomplete microscopic colitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10056979 Colitis microscopic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) SE (Completed) NL (Prematurely Ended) DK (Completed) LT (Completed) PT (Completed) AT (Completed) IT (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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