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Clinical trials for Buprenorphine

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   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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    81 result(s) found for: Buprenorphine. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2005-000240-82 Sponsor Protocol Number: P04279 Start Date*: 2005-05-05
    Sponsor Name:AESCA Pharma GesmbH
    Full Title: Randomized, controlled Study of Methadone and Buprenrphine in Hepatitis C patients in need of treatment
    Medical condition: hepatitis C patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-010360-41 Sponsor Protocol Number: BU0902 Start Date*: 2009-06-03
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France
    Medical condition: For both compounds, substitution treatment for opioid drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intra...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012346 Dependence on opiates LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-002159-41 Sponsor Protocol Number: Mo_top_Sb_100505 Start Date*: 2005-10-03
    Sponsor Name:Department of Anaesthesia & General Intensive Care Medicine
    Full Title: Investigation of the antihyperalgesic effect of topical buprenorphine in an UV-B induced inflammatory skin pain model in healthy volunteers
    Medical condition: Volunteer study with healthy volunteers using the UV-B-model as model of hyperalgesia.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000613-35 Sponsor Protocol Number: BUP/005/C Start Date*: 2005-07-18
    Sponsor Name:Novosis AG
    Full Title: A double-blind, multi - centre, reference-controlled, randomised phase III study to compare the analgesic efficacy and tolerability of two buprenorphine transdermal systems using three different do...
    Medical condition: chronic, severe cancer pain inadequately controlled with other analgesics
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    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: 2007-000329-22 Sponsor Protocol Number: 0602004 Start Date*: 2007-09-20
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A randomised, double blind, crossover pilot study of intravenous buprenorphine versus intravenous buprenorphine/ naloxone in patients with chronic pain.
    Medical condition: Chronic pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-006686-17 Sponsor Protocol Number: P05094 Start Date*: 2007-04-25
    Sponsor Name:Schering-Plough
    Full Title: Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent...
    Medical condition: For both compounds, substitution treatment for opiod drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intrav...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003816-38 Sponsor Protocol Number: PHRC-N/2017-FJ-01 Start Date*: 2020-11-09
    Sponsor Name:CHU DE NIMES
    Full Title: Add-on buprenorphine at analgesic doses for the treatment of severe suicidal ideas during a major depressive episode
    Medical condition: Treatment of severe suicidal ideas in patients suffers from a current major depressive episode
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004873 10083288 Clinical depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-005365-11 Sponsor Protocol Number: KF5303/01 Start Date*: 2006-03-31
    Sponsor Name:Grünenthal GmbH
    Full Title: A randomised, 2-arm, parallel group study assessing efficacy and tolerability of titrated transdermal buprenorphine in patients with moderate to severe chronic non malignant pain
    Medical condition: Moderate to severe chronic pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-004775-36 Sponsor Protocol Number: DETOX-11 Start Date*: 2012-01-30
    Sponsor Name:GET SRL
    Full Title: ''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms d...
    Medical condition: Oppiate addicts(heroin, methadone and buprenorphine)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10032707 Other specified drug dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-003592-48 Sponsor Protocol Number: BUP/006/C Start Date*: 2008-11-25
    Sponsor Name:Novosis AG
    Full Title: A double-blind, multi-centre, reference-controlled, randomised Phase III study to compare the analgesic efficacy and tolerability of a buprenorphine transdermal system in two different application ...
    Medical condition: Patients with chronic, severe cancer pain requiring strong opioids and inadequately controlled with other analgesics.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    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: 2011-002229-23 Sponsor Protocol Number: RB-UK-11-0018 Start Date*: 2012-05-09
    Sponsor Name:RB Pharmaceuticals Inc.
    Full Title: A randomised, double blind, placebo controlled, cross over study of the effects of Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate intravenous challenges in opioid dependen...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002302-43 Sponsor Protocol Number: CHDR1209 Start Date*: 2012-06-08
    Sponsor Name:Dr. Reddy's Laboratories Ltd.
    Full Title: A study to investigate the analgesic effects of buprenorphine and milnacipram in healthy volunteers.
    Medical condition: Pain therapeutics, neuropathic pain, nociceptive pain, synergism between opioids and TCA.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10054095 Neuropathic pain LLT
    14.1 10018065 - General disorders and administration site conditions 10066714 Acute pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    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: 2011-001088-28 Sponsor Protocol Number: BRIO Start Date*: 2016-01-14
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment
    Medical condition: Addiction to illicit heroin
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10019935 Heroin addiction LLT
    18.1 100000004873 10001127 Addiction to drugs LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002440-13 Sponsor Protocol Number: OMT-Satisfaction Start Date*: 2015-12-15
    Sponsor Name:Medical University Innsbruck
    Full Title: Treatment satisfaction and self-reported symptoms in patients under opioid maintenance therapy
    Medical condition: Opioid maintenance treatment (OMT) is an important factor in the medical care of opioid-dependent patients. Qualified OMT combined with general medical care and psychosocial support is effective in...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001195-13 Sponsor Protocol Number: 21651 Start Date*: 2005-08-18
    Sponsor Name:University of Leeds
    Full Title: The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project: An open label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for prison ...
    Medical condition: Opiate addiction (detoxification from illicit opiates)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-001356-20 Sponsor Protocol Number: 0602001 Start Date*: 2006-06-05
    Sponsor Name:Reckitt Benckiser (UK) Limited
    Full Title: A preliminary single dose, three-way, double-blind, placebo-controlled crossover study of intravenous buprenorphine/naloxone in the treatment of neuropathic pain of diabetic neuropathy origin.
    Medical condition: Neuropathic pain
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-016079-32 Sponsor Protocol Number: AS Start Date*: 2010-12-02
    Sponsor Name:Universitätsklinik für Psychiatrie - Spezialambulanz für Abhangigkeitserkrankungen
    Full Title: Auswirkungen der Substitutionstherapie mit Methadon und Buprenorphin auf die kognitiven Funktionen.
    Medical condition: Untersuchung der kognitiven Leistungsfähigkeit bei Opiatabhängigen, die sich in der Substitutionstherapie unter Methadon und unter Buprenorphin befinden.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    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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