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Clinical trials for Hydromorphone

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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    • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    37 result(s) found for: Hydromorphone. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2009-014518-83 Sponsor Protocol Number: C_21060_P3_04 Start Date*: 2009-10-07
    Sponsor Name:Acino Supply AG
    Full Title: A double blind, two-period cross-over study to compare the analgesic efficacy and tolerability of a new modified release formulation of hydromorphone (Hydromorphone hydrochloride 8 mg, 16 mg, and 2...
    Medical condition: chronic, severe pain adequately treated with Palladon® retard 8 mg or more twice daily
    Disease: Version SOC Term Classification Code Term Level
    12.0 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000903-10 Sponsor Protocol Number: 26022016 Start Date*: 2017-01-04
    Sponsor Name:Oulu University Hospital
    Full Title: Efficacy and blood concentrations of epidural hydromorphone in labour
    Medical condition: Labour pain
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005315-18 Sponsor Protocol Number: HMX3501 Start Date*: 2009-07-21
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio w...
    Medical condition: Moderate to severe chronic non-cancer or cancer pain with opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    14.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    14.0 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) GB (Completed) FR (Completed) NL (Completed) DE (Completed) AT (Completed) BE (Completed) DK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-003648-31 Sponsor Protocol Number: PKPDHM-001 Start Date*: 2011-11-17
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Pharmacokinetic-pharmacodynamic modeling of the postoperative pain sensation during patient-controlled analgesia with target-controlled infusion of Hydromorphone, taking into account the interactio...
    Medical condition: Pain therapy after elective cardiac surgery
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004471-37 Sponsor Protocol Number: 1824/DEV Start Date*: 2012-02-14
    Sponsor Name:Develco Pharma Schweiz AG
    Full Title: Randomised, double-blind, cross-over Phase III study to investigate the efficacy and safety of hydromorphone after once daily administration of Hydromorphone HCl PR tablets XL in comparison to twic...
    Medical condition: Chronic severe cancer or non-cancer pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-005187-24 Sponsor Protocol Number: OROS-ANA-3001 Start Date*: 2005-08-16
    Sponsor Name:JANSSEN-CILAG
    Full Title: Randomized, open label, comparative parallel group study to assess efficacy and safety of flexible dosages of OROS hydromorphone once-daily compared to sustained release oxycodone twice-daily in su...
    Medical condition: Treatment of chronic non-malignant pain
    Disease: Version SOC Term Classification Code Term Level
    6.1 10033371 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2014-004088-19 Sponsor Protocol Number: TCI-PCA-002 Start Date*: 2014-12-12
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Postoperative pain treatment after elective cardiac surgery using patient-controlled target-controlled infusion (TCI-PCA) with hydromorphone vs. patient-controlled analgesia (PCA) with morphine
    Medical condition: Postoperative pain treatment after elective cardiac surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015931-33 Sponsor Protocol Number: 42801PAI3010 Start Date*: 2010-05-07
    Sponsor Name:JANSSEN-CILAG
    Full Title: An open label, prospective, multicenter, single-arm clinical trial to investigate the safety and the analgesic effectiveness of a low dose (4 mg) OROS hydromorphone hydrochloride as starting dose...
    Medical condition: patients with chronic moderate to severe malignant pain which has not been adequately controlled by previous treatment with NSAIDs, COX-2 inhibitors or paracetamol.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-013022-16 Sponsor Protocol Number: ZonMw 80-82100-98-096/11510014 Start Date*: 2009-10-21
    Sponsor Name:Erasmus MC [...]
    1. Erasmus MC
    2. ZonMw
    Full Title: Effecten en bijwerkingen van opioïden: een studie naar de rol van farmacokinetische en farmacogenetische heterogeniteit.
    Medical condition: Nociceptive cancer pain for which strong opioids are needed
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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
    23.1 100000004873 10013658 Drug addiction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006911-60 Sponsor Protocol Number: 42801PAI3001 Start Date*: 2007-06-15
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: Randomised, double-blind, placebo-controlled, parallel-group trial to investigate the analgesic effect of OROS hydromorphone hydrochloride in comparison with placebo in subjects with moderate to se...
    Medical condition: moderate to severe pain induced by osteoarthritis of the hip or the knee
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003239 Arthralgia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2005-002348-24 Sponsor Protocol Number: FT-018-IM Start Date*: 2006-08-11
    Sponsor Name:Nycomed Danmark ApS
    Full Title: A double-blind, randomised, placebo-controlled trial confirming the efficacy of intranasal fentanyl titrated to 50, 100 or 200 µg with an open long-term safety follow-up in cancer patients with bre...
    Medical condition: Breakthrough Pain
    Disease: Version SOC Term Classification Code Term Level
    8.1 10064556 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FI (Completed) DK (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002347-82 Sponsor Protocol Number: FT-017-IM Start Date*: 2006-04-05
    Sponsor Name:Nycomed Danmark ApS
    Full Title: Intranasal fentanyl for the treatment of breakthrough pain in cancer patients: A randomised, double-blind, placebo-controlled, cross-over confirmatory trial testing the doses 50, 100 and 200 µg fen...
    Medical condition: Breakthrough Pain
    Disease: Version SOC Term Classification Code Term Level
    8.1 10064556 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001358-41 Sponsor Protocol Number: VERCLBP002 Start Date*: 2023-02-27
    Sponsor Name:Vertanical GmbH
    Full Title: Multicentre, randomized, open-label study to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in the treatment of patients with chronic non-specific low back pain.
    Medical condition: Chronic non-specific low back pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2008-002292-27 Sponsor Protocol Number: NonOnco2008 Start Date*: 2008-06-23
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Long term opioid administration in no-oncologic chronic pain: open label, prospective study on efficacy, safety and pharmacokinetic factors
    Medical condition: chronic pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-002273-12 Sponsor Protocol Number: Onco2008 Start Date*: 2008-06-23
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Long term opioid administration in oncologic chronic pain: open label, prospective study on efficacy, safety and pharmacogenetic factors.
    Medical condition: oncologic chronic pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-005393-31 Sponsor Protocol Number: CL_700_015_PRO Start Date*: 2008-08-25
    Sponsor Name:Akela Pharma Inc
    Full Title: A Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial to Evaluate Efficacy and Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration for Bre...
    Medical condition: Breakthrough pain in opioid tolerant cancer patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Ongoing) CZ (Completed) HU (Ongoing) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004359-35 Sponsor Protocol Number: R331333PAI3037 Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen Research & Development LLC
    Full Title: An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 y...
    Medical condition: The management of acute postoperative pain in hospitalized paediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10036236 Postoperative pain relief LLT
    17.0 100000004863 10054711 Postoperative pain LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing) DE (Completed) GB (Completed) ES (Completed) AT (Completed) FR (Ongoing) PL (Completed) HR (Completed) HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-004609-26 Sponsor Protocol Number: Methadone-FR-CL0390 Start Date*: 2011-12-02
    Sponsor Name:Laboratoires Bouchara-Recordati
    Full Title: Evaluation of the efficacy and safety of two methadone titration methods for the treatment of cancer-related pain with inadequate pain relief or intolerable side effects when treated with level 3 o...
    Medical condition: Treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001520-66 Sponsor Protocol Number: UC-0106/1607 Start Date*: 2018-06-13
    Sponsor Name:UNICANCER
    Full Title: Efficacy and safety of fentanyl citrate in painful access induced during diagnostic or therapeutic examinations in cancer patients
    Medical condition: Cancer patient
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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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