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Clinical trials for Buccal administration

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   44334   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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    66 result(s) found for: Buccal administration. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2006-005788-24 Sponsor Protocol Number: BA2005/21/02 Start Date*: 2007-02-15
    Sponsor Name:Bioalliance Pharma
    Full Title: A Randomised, Double-Blind, Single dose, One-Day Early Administration, Multicentre Study comparing the Efficacy and Safety of Acyclovir Lauriad 50 mg muco-adhesive buccal tablet to matching Placebo...
    Medical condition: Herpes labialis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003315-60 Sponsor Protocol Number: A201 Start Date*: 2020-11-10
    Sponsor Name:Criceto IKM B.V.
    Full Title: A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease
    Medical condition: Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-001575-30 Sponsor Protocol Number: 31638 Start Date*: 2008-08-18
    Sponsor Name:University of Nottingham
    Full Title: A randomised, open-label, single-centre, pharmacokinetic study of a single dose of lorazepam administered by the intranasal and buccal route in healthy adult volunteers
    Medical condition: Status epilepticus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041962 Status epilepticus LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-006015-57 Sponsor Protocol Number: RBHP2011PICKERING5 Start Date*: 2012-04-05
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10066714 Acute pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005797-32 Sponsor Protocol Number: Uni-Koeln-1412 Start Date*: 2013-02-28
    Sponsor Name:University of Cologne
    Full Title: Effentora® for Dyspnoea (EffenDys) - Fentanyl buccal tablet (FBT) for the relief of episodic dyspnoea (ED) in cancer patients: an open label, randomized, morphine-controlled, crossover, phase II trial
    Medical condition: Patients with cancer suffering from episodes of dyspnoea (ED)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-003843-28 Sponsor Protocol Number: STH13565 Start Date*: 2005-03-18
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: The acute effects of testosterone administration in patients with pulmonary hypertension
    Medical condition: Pulmonary Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005922-29 Sponsor Protocol Number: 20715650 Start Date*: 2006-08-18
    Sponsor Name:Anæstesisektor Nordjylland
    Full Title: Præhospital smertebehandling med Actiq®-slikkepind (Fentanyl 400 µg/dosis) af patienter visiteret præhospitalt med akut STEMI
    Medical condition: ST-elevations myokardie infarkt
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000226-26 Sponsor Protocol Number: SHP615-301 Start Date*: 2020-02-13
    Sponsor Name:Shire
    Full Title: A Phase 3, Multicenter, Open-label Study to Determine the Efficacy, Safety, and Pharmacokinetics of Buccally Administered MHOS/SHP615 in Pediatric Patients with Status Epilepticus (Convulsive) in t...
    Medical condition: Acute Convulsive Seizures
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002051-10 Sponsor Protocol Number: SHP615-302 Start Date*: 2021-04-13
    Sponsor Name:Takeda Development Center, Americas (TDC Americas)
    Full Title: A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients with Status Epilepticus (Convulsive) in Community Settings
    Medical condition: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-005423-37 Sponsor Protocol Number: GHRMRIPH1001 Start Date*: 2021-02-05
    Sponsor Name:Raincy Montfermeil intercommunal hospital group
    Full Title: Impact évaluation of an ivermectin single dose administration in the early phase of COVID-19 to negative viral load in SARS-CoV-2 determined by RT-PCR_ IVERCoV.
    Medical condition: patients with COVID 19 symptoms for less than 72 hours
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001841-24 Sponsor Protocol Number: C25608/4027/BP/EU Start Date*: 2008-08-04
    Sponsor Name:Cephalon France
    Full Title: A European Multicenter Open-label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
    Medical condition: Breakthrough Pain (BTP) in cancer patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064556 Breakthrough pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) FR (Completed) IE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004577-30 Sponsor Protocol Number: EARLY-GENE Start Date*: 2022-03-11
    Sponsor Name:FUNDACION INVESTIGACION BIOMEDICA HOSPITAL PUERTA DE HIERRO MAJADAHONDA
    Full Title: EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial)
    Medical condition: Dilated Cardiomyopathy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005801-20 Sponsor Protocol Number: 2008_23/0832 Start Date*: 2009-04-08
    Sponsor Name:Centre Hospitalier Régional et Universitaire de Lille
    Full Title: Etude d’efficacité et d’acceptabilité du méthylphénidate dans les troubles de la marche de la maladie de Parkinson : Etude multicentrique en double aveugle versus placebo.
    Medical condition: Troubles de la marche
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056242 Parkinsonian gait PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-002220-37 Sponsor Protocol Number: UP-CLI-2020-001 Start Date*: 2021-02-24
    Sponsor Name:UNITHER Pharmaceuticals
    Full Title: Comparison of the analgesic effect of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use and two different doses of an oral paracetamol form controlled versus placebo in patients s...
    Medical condition: Symptomatic short-term treatment of moderate pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006379-65 Sponsor Protocol Number: 02A801 Start Date*: 2008-10-27
    Sponsor Name:ISTITUTO AUXOLOGICO ITALIANO
    Full Title: Evaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease
    Medical condition: sperimentation only in patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005009-30 Sponsor Protocol Number: Start Date*: 2016-05-04
    Sponsor Name:Gloucestershire Hospitals NHS Foundation Trust and
    Full Title: An open label, randomised controlled feasibility pilot study to evaluate whether nasal fentanyl alone and in combination with buccal midazolam give better symptom control to dying patients when com...
    Medical condition: Adult hospice in-patients with terminal cancer who are thought to be in the last 1 - 2 weeks of life
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10059513 Palliative care PT
    20.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-024445-78 Sponsor Protocol Number: MANS10 Start Date*: 2011-02-28
    Sponsor Name:Magle AB
    Full Title: Nicotine plasma concentrations and subjective effects of a single dose of Nicachet 4 mg nicotine oromucosal powder in pouch compared with 4mg Nicorette chewing gum and 1mg Nicorette nasal spray.
    Medical condition: Smoking cessation
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001634-17 Sponsor Protocol Number: 2015.0704 Start Date*: 2015-12-24
    Sponsor Name:University Medical Center Groningen
    Full Title: 18FDHT-PET to visualize the effect on the androgen receptor level by bicalutamide
    Medical condition: androgen receptor positive metastatic breast cancer patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-005056-16 Sponsor Protocol Number: ATORV/IMAPERIPROC Start Date*: 2007-10-19
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: Atorvastatin at high dosage before coronary stent surgery: effect on peri-procedure miocardic stroke .
    Medical condition: elective PCI in de novo coronaric lesions
    Disease: Version SOC Term Classification Code Term Level
    6.1 10047065 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001337-40 Sponsor Protocol Number: BXCL501-105 Start Date*: 2021-10-05
    Sponsor Name:BioXcel Therapeutics, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER
    Medical condition: Subject that meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subjec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    20.0 10037175 - Psychiatric disorders 10039629 Schizophrenia childhood LLT
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
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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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