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Clinical trials for Opioid

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   44356   clinical trials with a EudraCT protocol, of which   7382   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    594 result(s) found for: Opioid. Displaying page 9 of 30.
    EudraCT Number: 2015-005179-25 Sponsor Protocol Number: 402-C-326 Start Date*: 2016-06-10
    Sponsor Name:Pacira Pharmaceuticals, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block with EXPAREL for Postsurgical Analgesia in Subjects Un...
    Medical condition: Total Knee Arthroplasty
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10038286 Regional nerve block LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-002187-24 Sponsor Protocol Number: D3820C00007 Start Date*: 2011-11-04
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
    Medical condition: Opioid-induced constipation (OIC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-005010-36 Sponsor Protocol Number: CR-TFB-2013/502 Start Date*: 2014-01-08
    Sponsor Name:Thomas Fichtner Bendtsen
    Full Title: The effect of protracted saphenous nerve and obturator nerve blockade versus saphenous nerve blockade versus local infiltration analgesia in opioid consumption, pain, blockade duration of action an...
    Medical condition: The medical condition to be examined in this study is the first postoperative period after total knee replacement with a view to pain management.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10038286 Regional nerve block LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-004920-40 Sponsor Protocol Number: AFFECT Start Date*: 2021-03-22
    Sponsor Name:Vestre Viken HF
    Full Title: Affective effects of pre-surgery opioids (AFFECT): a randomized double-blind controlled trial
    Medical condition: Healthy adult surgery patients. Health status ASA1 or ASA2 as categorised by a medical doctor at the hospital based on medical history, physical examination. The American Society of Anesthesiologis...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000242-17 Sponsor Protocol Number: Protocol_PPB_TKA_14012021 Start Date*: 2021-03-12
    Sponsor Name:Region Hospital Silkeborg
    Full Title: The effect of the popliteal plexus block on postoperative opioid consumption, pain, muscle strength and mobilization after total knee arthroplasty - a randomized, controlled, blinded study
    Medical condition: Postoperative pain following a total knee arthroplasty surgery
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-000107-36 Sponsor Protocol Number: VER-CLBP-001 Start Date*: 2021-03-24
    Sponsor Name:Vertanical GmbH
    Full Title: Proof of efficacy, maintenance of efficacy, long-term safety and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in a multicenter study in...
    Medical condition: For the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain r...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007690-21 Sponsor Protocol Number: 42160443PAI2001 Start Date*: 2009-10-02
    Sponsor Name:Janssen Cilag International NV
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Foll...
    Medical condition: Subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Completed) PT (Completed) IT (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-002398-57 Sponsor Protocol Number: OXN3001 Start Date*: 2005-11-23
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomized, double-blind, parallel-group, multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of >= 20 mg/day ...
    Medical condition: Moderate to severe non-malignant pain that requires around the clock opioid therapy and also have constipation secondary to opioid treatment.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001772-11 Sponsor Protocol Number: OXN2505 Start Date*: 2014-01-23
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: An exploratory, double-blind, double-dummy, randomised, 2-period, crossover, Phase IIa study to assess the influence of oxycodone/naloxone prolonged-release tablets (OXN PR) and oxycodone prolonged...
    Medical condition: The intended indication is: Chronic severe non malignant pain, requiring opioids.
    Disease: Version SOC Term Classification Code Term Level
    16.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-003245-38 Sponsor Protocol Number: OFA_GAL_21 Start Date*: 2022-03-08
    Sponsor Name:Unai Ortega Mera
    Full Title: Randomized clinical trial to compare the efficacy of opioid-free versus traditional balanced anesthesia in laparoscopic colorectal surgery
    Medical condition: laparoscopic colorectal surgery
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-000854-30 Sponsor Protocol Number: 3200K1-4000-WW(B2541005) Start Date*: 2009-02-27
    Sponsor Name:Salix Pharmaceuticals Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Addition...
    Medical condition: Opioid-induced constipation in subjects with advanced illness
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Prematurely Ended) FR (Completed) FI (Prematurely Ended) DK (Prematurely Ended) PT (Completed) SE (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    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: 2008-002670-36 Sponsor Protocol Number: OXN3503 Start Date*: 2009-01-30
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with...
    Medical condition: Pain, locomotor function and improvement in constipation in osteoarthritis patients taking opioids
    Disease: Version SOC Term Classification Code Term Level
    9.1 10031161 Osteoarthritis LLT
    9.1 10021175 Iatrogenic constipation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed) NL (Completed) ES (Completed) AT (Completed) FI (Completed) BE (Completed)
    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: 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: 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: 2005-003510-15 Sponsor Protocol Number: OXN3006 (incl. Admin. Change 1) Start Date*: 2006-03-06
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of ...
    Medical condition: Moderate to severe chronic non-malignant pain that requires around-the-clock opioid therapy and also have constipation secondary to opioid treatment.
    Disease: Version SOC Term Classification Code Term Level
    7.1 10003988 pt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) ES (Completed) CZ (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2012-003275-19 Sponsor Protocol Number: 402-C-322 Start Date*: 2013-01-29
    Sponsor Name:Pacira Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Intercostal Nerve Block with Liposome Bupivacaine in Subjects Undergo...
    Medical condition: Intercostal Nerve Block for Posterolateral Thoracotomy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10038286 Regional nerve block LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-003752-19 Sponsor Protocol Number: OXN3401 Start Date*: 2005-02-01
    Sponsor Name:Mundipharma Research GmbH & Co.KG
    Full Title: A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with ...
    Medical condition: Moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003988 pt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DK (Completed) SK (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003498-13 Sponsor Protocol Number: HIP/FUSION#1 Start Date*: 2016-03-18
    Sponsor Name:Institut for Klinisk Medicin, Aarhus Universitet
    Full Title: Surgical anesthesia for elective hip surgery - hemodynamic effect of lumbosacral plexus blockade compared to continuous spinal anesthesia
    Medical condition: No specific medical condition is investigated. The objective of the investigation is to compare two methods for surgical anesthesia for total hip replacement.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10068084 Anesthesia procedure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    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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