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Clinical trials for Opioid agonist therapy

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    19 result(s) found for: Opioid agonist therapy. Displaying page 1 of 1.
    EudraCT Number: 2004-001182-18 Sponsor Protocol Number: SB-767905/011 Start Date*: 2004-08-19
    Sponsor Name:GlaxoSmithKline R & D Limited
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfu...
    Medical condition: Opioid-induced Bowel Dysfunction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-001814-14 Sponsor Protocol Number: ABD101684 Start Date*: 2005-11-21
    Sponsor Name:GlaxoSmithKline R&D Limited
    Full Title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunc...
    Medical condition: Opioid-Induced Bowel Dysfunction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FI (Prematurely Ended) IE (Completed) CZ (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2022-002462-32 Sponsor Protocol Number: SHW01 Start Date*: 2022-12-09
    Sponsor Name:Suchthilfe Wien gGmbH
    Full Title: Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.
    Medical condition: Opioid dependence: Opioid dependence is a serious and usually chronic disease that requires treatment, encompasses various psychological and physical dimensions, and is associated with concomitant ...
    Disease: Version SOC Term Classification Code Term Level
    26.1 10037175 - Psychiatric disorders 10013658 Drug addiction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004981-37 Sponsor Protocol Number: BMXBAR01 Start Date*: 2022-01-19
    Sponsor Name:Helse Bergen HF
    Full Title: Benzodiazepine maintenance treatment for patients with benzodiazepine dependence undergoing opioid agonist therapy (BMX-BAR)
    Medical condition: Benzodiazepine dependence
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-009377-10 Sponsor Protocol Number: NAL-OIC-01 Start Date*: 2009-05-27
    Sponsor Name:SLA Pharma (UK) Ltd
    Full Title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Efficacy Study of Naloxone SR capsules in Subjects with Constipation due to Opioids ta...
    Medical condition: Opioid Induced Constipation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021175 Iatrogenic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003238-15 Sponsor Protocol Number: Schaefers0711 Start Date*: 2012-12-12
    Sponsor Name:KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH
    Full Title: Quality of analgesia and side effect incidence and severity during postoperative pain management with Palexia® compared to Targin®
    Medical condition: Management of postoperative pain in trauma surgery patients (adults) requiring postoperative opiates for the management of postoperative pain.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002237-11 Sponsor Protocol Number: ARC Start Date*: 2012-12-17
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: Effectiveness of Adaptive Opioid Agonist Maintenance Pharmacotherapy and Behavioural Therapy for Opioid Use Disorder.
    Medical condition: Opiate dependency disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-022991-29 Sponsor Protocol Number: SMR/0211OBD-1033 Start Date*: 2011-02-01
    Sponsor Name:Sucampo Pharma Americas, Inc.
    Full Title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Patients with Opioid-induced Bowel Dysfunction
    Medical condition: Opioid-induced Bowel Dysfunction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10061247 Intestinal functional disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-000013-20 Sponsor Protocol Number: 2018-000013-20 Start Date*: 2018-05-07
    Sponsor Name:KU Leuven
    Full Title: Placebo-controlled crossover study of the ability of Naloxegol to reverse opioid effect on colonic motor patterns in healthy volunteers
    Medical condition: This study will be performed in healthy volunteers.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002590-38 Sponsor Protocol Number: 17777 Start Date*: 2016-12-14
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, placebo-controlled Phase III study of darolutamide (ODM-201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastati...
    Medical condition: Metastatic hormone-sensitive prostate cancer (mHSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) BE (Completed) ES (Completed) FI (Completed) DE (Completed) CZ (Completed) NL (Completed) PL (Completed) FR (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004460-63 Sponsor Protocol Number: EXPO Start Date*: 2019-07-01
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): An Open Label Randomised Controlled Trial of Injectable Depot Maintenance Buprenorphine versus Standard-Of-Care Oral Maintenance Opi...
    Medical condition: Opiod addiction
    Disease: Version SOC Term Classification Code Term Level
    23.1 10037175 - Psychiatric disorders 10013658 Drug addiction LLT
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-004482-41 Sponsor Protocol Number: SUB3001 Start Date*: 2006-04-07
    Sponsor Name:Napp Pharmaceuticals Research Limited
    Full Title: A randomised, double blind, double-dummy, parallel group study to compare the efficacy and tolerability of morphine sulphate prolonged release capsules and methadone oral solution in once per day a...
    Medical condition: Subjects have a diagnosis of opiate addiction.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001426-99 Sponsor Protocol Number: XL184–306 Start Date*: 2012-07-11
    Sponsor Name:Exelixis, Inc.
    Full Title: A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancer
    Medical condition: castration-resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000248-23 Sponsor Protocol Number: C3441052 Start Date*: 2021-10-22
    Sponsor Name:Pfizer Inc.
    Full Title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
    Medical condition: Metastatic Castration-sensitive Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) SK (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) BG (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003275-20 Sponsor Protocol Number: G-0034 Start Date*: 2005-10-07
    Sponsor Name:Cell Genesys Inc.
    Full Title: A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer...
    Medical condition: Metastatic Hormone-Refractory Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    8.0 10036909
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) BE (Completed) IT (Prematurely Ended) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005201-27 Sponsor Protocol Number: D361EC00001 Start Date*: 2022-06-27
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Cas...
    Medical condition: Metastatic Castration Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Ongoing) GR (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001787-36 Sponsor Protocol Number: 1333-GUCG Start Date*: 2015-09-14
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metas...
    Medical condition: Castration resistant prostate cancer patients metastatic to bone.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned) PL (Trial now transitioned) IE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-002094-23 Sponsor Protocol Number: EORTC 30021 Start Date*: 2004-12-20
    Sponsor Name:EORTC
    Full Title: Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPC
    Medical condition: Patients with Hormone- Refractory Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    7.0 10001186 LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) DE (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-003820-36 Sponsor Protocol Number: BAY1841788/17712 Start Date*: 2014-07-25
    Sponsor Name:Bayer AG
    Full Title: A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (DCM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    Medical condition: High-risk, non-metastatic castration-resistant prostate cancer (MedDRA: hormonerefractory prostate cancer)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066489 Progression of prostate cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) HU (Completed) FI (Completed) LV (Completed) CZ (Completed) AT (Completed) GB (Completed) SK (Completed) DE (Completed) PT (Completed) IT (Completed) BE (Completed) BG (Completed) FR (Completed) PL (Completed) RO (Completed) LT (Completed) EE (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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