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Clinical trials for Sublingual 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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    70 result(s) found for: Sublingual administration. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2013-003319-23 Sponsor Protocol Number: SLF_SCMO_0113 Start Date*: 2013-11-07
    Sponsor Name:Fondazione IRCCS Istituto Nazionale dei Tumori
    Full Title: SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE FOR THE MANAGEMENT OF SEVERE CANCER PAIN EPISODES IN PATIENTS ON OPIOID TREATMENT: A DOUBLE-BLIND RANDOMIZED NON–INFERIORITY TRIAL.
    Medical condition: pain due to cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-001521-19 Sponsor Protocol Number: MS04062004 Start Date*: 2004-09-01
    Sponsor Name:SEVAPHARMA a.s.
    Full Title: An open clinical trial on teh efficacy of H-AL pollens (Grass mixture I) administered orally and sublingually in patients with indicated allergen immunotherapy (AIT) with Type I allergy mediated by...
    Medical condition: Type I allergy to pollens mediated by IgE antibodies
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-007580-24 Sponsor Protocol Number: EB70 Start Date*: 2008-02-08
    Sponsor Name:Emotional Brain
    Full Title: A double blind, randomized, 3-arm placebo controlled study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subj...
    Medical condition: Hypoactive sexual desire disorder and female sexual arousal disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016790-15 Sponsor Protocol Number: EB78 Start Date*: 2009-12-03
    Sponsor Name:Emotional Brain
    Full Title: A double blind, randomized, cross-over placebo controlled study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female...
    Medical condition: Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002735-32 Sponsor Protocol Number: EB72 Start Date*: 2008-06-24
    Sponsor Name:Emotional Brain
    Full Title: A double blind, randomized, placebo controlled cross-over study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female...
    Medical condition: Hypoactive sexual desire disorder and female sexual arousal disorder in combination with SSRI use.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000314-12 Sponsor Protocol Number: SC2-90049-003 Start Date*: 2005-10-14
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-...
    Medical condition: Parkinson's Disease aggravated
    Disease: Version SOC Term Classification Code Term Level
    7.0 10034006 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005139-61 Sponsor Protocol Number: EB064 Start Date*: 2006-10-24
    Sponsor Name:Emotional Brain
    Full Title: Neural correlates of sexual arousal during treatment of testosterone combined with sildenafil in healthy female subjects with FSD. Effects of differing levels of attentional engagement on neural co...
    Medical condition: Hypoactive sexual desire disorder and female sexual arousal disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002435-93 Sponsor Protocol Number: UNITHER/UN/07/001 Start Date*: 2007-09-20
    Sponsor Name:UNITHER PHARMACEUTICALS
    Full Title: Evaluation d'une solution hydro-alcoolique de sumatriptan administrée par voie sublinguale dans le traitement d'une crise d'algie vasculaire de la face, à la dose de 2mg, 4mg ou 6mg déterminée par ...
    Medical condition: Cluster headaches
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002009-31 Sponsor Protocol Number: EB069 Start Date*: 2007-06-13
    Sponsor Name:Emotional Brain BV
    Full Title: A double blind randomized placebo controlled cross-over study to validate the distinction between women with different levels of attention and valence direction for erotic stimuli, in relation with...
    Medical condition: Hypoactive sexual desire disorder and female sexual arousal disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-003824-36 Sponsor Protocol Number: SATEME-08 Start Date*: 2005-09-15
    Sponsor Name:Fundació Institut Català de Farmacologia
    Full Title: Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to refe...
    Medical condition: Chemotherapy induced nausea and vomiting
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002871-32 Sponsor Protocol Number: Rifabupre Start Date*: 2012-08-28
    Sponsor Name:Turku University hospital
    Full Title: Effects of rifampicin on the pharmacokinetics and pharmacodynamics of sublingual and intravenous buprenorphine: A four-phase cross-over study in healthy subjects.
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001903-10 Sponsor Protocol Number: OX51-002 Start Date*: 2012-08-07
    Sponsor Name:Orexo AB
    Full Title: A randomized, double-blind, placebo-controlled, dose finding trial using sublingual alfentanil to alleviate pain associated with a prostate biopsy procedure
    Medical condition: Pain associated with prostate biopsy.
    Disease: Version SOC Term Classification Code Term Level
    16.0 10022891 - Investigations 10004857 Biopsy prostate PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed) CZ (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-004250-15 Sponsor Protocol Number: Start Date*: 2018-06-08
    Sponsor Name:University Hospitals Birmingham
    Full Title: A prospective, phase II, single centre, cross-sectional, randomised trial investigating Dehydroepiandrosterone and it's Pharmacokinetics in Trauma
    Medical condition: DHEA depletion in trauma and hip fracture patients.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022891 - Investigations 10056629 Dehydroepiandrosterone decreased PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-020953-14 Sponsor Protocol Number: PosaBupreversion1.0 Start Date*: 2010-08-12
    Sponsor Name:Derartment of Anaesthesiology and Intensive Care, Turku University Hospital
    Full Title: Effects of posaconazole and voriconazole on the pharmacokinetics and pharmacodynamics of sublingual buprenorphine: A three-phase double-blind cross-over study in healthy subjects.
    Medical condition: - healty volunteer subjects - The study is aimed to examine the possible interactions of low-dose sublingual buprenorphine with posaconazole and voriconazole.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000257-56 Sponsor Protocol Number: EB065 Start Date*: 2007-02-05
    Sponsor Name:Emotional Brain BV
    Full Title: Neural correlates of sexual arousal during treatment of testosterone combined with sildenafil in healthy female subjects with FSD. Effects of differing levels of attentional engagement on neural co...
    Medical condition: Hypoactive sexual desire disorder and female sexual arousal disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-003230-18 Sponsor Protocol Number: Study No.: PRG-BUP-03/01 Start Date*: 2005-08-04
    Sponsor Name:Barts and The London NHS Trust
    Full Title: A prospective double-blind, randomised, cross-over trial to compare the effects of adding buprenorphine or morphine to Transtec for 'breakthrough' pain in patients with severe pain due to osteoarth...
    Medical condition: Patients with severe chronic pain (6 or more on a 11-point NRS) in the hips or knees due to osteoarthritis, failing on their current analgesic therapy. ICD 10: M16.50 & M17.30
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004522-10 Sponsor Protocol Number: Lais-Amb-11 Start Date*: 2012-05-06
    Sponsor Name:LOFARMA
    Full Title: Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergic rhinoconjunctivitis to pollen of Ambrosia
    Medical condition: rhinoconjunctivitis allergic to ragweed pollen
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021428 - Immune system disorders 10054928 Allergy to plants PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014580-39 Sponsor Protocol Number: SP-B-02 Start Date*: 2010-01-05
    Sponsor Name:ALK-Abelló Arzneimittel GmbH
    Full Title: A multicentre randomised Phase II clinical pilot study to compare the pharmacodynamic efficacy and tolerability of the sublingual and the vestibular administration route for SLITonePLUS® Birch
    Medical condition: Birch pollen induced allergic rhinoconjunctivitis requiring treatment during the birch pollen season
    Disease: Version SOC Term Classification Code Term Level
    12.0 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003560-49 Sponsor Protocol Number: MD2012/01XP Start Date*: 2012-10-11
    Sponsor Name:Macarthys Laboratories Limited (trading as Martindale Pharma)
    Full Title: A PHASE II, RANDOMISED, SINGLE CENTRE, OPEN-LABEL, TWO-ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF BUPRENORPHINE ORAL LYOPHILISATE (XPRENOR ®) IN COMPARISON WITH BUPRENORPHINE SUBLINGUAL TABL...
    Medical condition: Opioid dependency
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10001125 Addiction LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-005200-13 Sponsor Protocol Number: SafePed002 Start Date*: 2015-07-09
    Sponsor Name:Ghent University
    Full Title: study of the pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate - route of administration in the pediatric patient population - SAFEPEDRUG
    Medical condition: therapeutic population: monosympthomatic enuresis nocturna diagnostic population: children with a history of a urinary tract infection or suspicion of renal damage who need a renal concentration...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (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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