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Clinical trials for 4 mg single dose

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3,184 result(s) found for: 4 mg single dose. Displaying page 26 of 160.
    EudraCT Number: 2007-002964-90 Sponsor Protocol Number: 27919 Start Date*: 2011-05-05
    Sponsor Name:Newron Pharmaceuticals SpA
    Full Title: A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathi...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FI (Prematurely Ended) FR (Completed) HU (Completed) ES (Completed) NL (Completed) EE (Completed) AT (Completed) SK (Completed) DE (Completed) GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-005127-40 Sponsor Protocol Number: M13-383 Start Date*: 2012-03-01
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Placebo- and Active Controlled Study of the Electrophysiological Effects of ABT-639 on Spontaneous Activity in C Nociceptors in Patients with Diabetic Peripheral Neuropa...
    Medical condition: Diabetec Neuropathic Pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10012683 Diabetic peripheral neuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000613-38 Sponsor Protocol Number: 1216.20 Start Date*: 2006-07-24
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on day 1...
    Medical condition: Male or female patients older than 60 years of age with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy. Leukocyte count sh...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-004267-30 Sponsor Protocol Number: Gebro-III-21-10 Start Date*: 2005-02-21
    Sponsor Name:Gebro Pharma GmbH
    Full Title: Efficacy and Tolerability of Dexibuprofen Film coated tablets in Comparison to Ibuprofen in Children and Adolescents with Tonsillopharyngitis
    Medical condition: Tonsillopharyngitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002641-39 Sponsor Protocol Number: PALO-05-01 Start Date*: 2006-10-17
    Sponsor Name:Helsinn Healthcare SA
    Full Title: Open-Label Pilot Study to Evaluate the Efficacy of Palonosetron Associated with Aprepitant (Emend) and Dexamethasone in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy (HEC)
    Medical condition: This is a Phase 4, open-label, pilot study to evaluate the Efficacy of Plaonosetron associated with Aprepitant (Emend) and Dexamethasone in preventing nausea and vomitting in chemotherapy-naïve pat...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002037-59 Sponsor Protocol Number: CSPH-EX-0414 Start Date*: 2015-04-01
    Sponsor Name:Exalenz BioScience Ltd.
    Full Title: Clinical Study of the BreathID® LF System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis
    Medical condition: Compensated Liver Cirrhosis and indication to undergo HVPG testing
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004351-20 Sponsor Protocol Number: 01122018v2 Start Date*: 2019-02-01
    Sponsor Name:Aarhus University Hospital
    Full Title: Intraoperative methadone in same-day hysterectomy: a prospective, double-blind, randomised controlled trial
    Medical condition: Same-day hysterectomy
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10023692 Laparoscopically assisted hysterectomy LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-001284-27 Sponsor Protocol Number: ENHANCE Start Date*: 2022-09-07
    Sponsor Name:Med. Univ. Wien, Klinik f. Innere Med I, Onkologie
    Full Title: H1-antihistaminE treatment in combiNation with immunotHerapy in pAtieNts with advanced non small cell lung canCEr: A single- center phase II trial
    Medical condition: NSCLC
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-020063-21 Sponsor Protocol Number: ILUVIT1 Start Date*: 2010-06-15
    Sponsor Name:Charité-Universitätsmedizin
    Full Title: “A 20-week open-label study to assess the efficacy and safety of single doses of Ilaris® (Canakinumab, ACZ885) in patients with active, refractory urticarial vasculitis”
    Medical condition: Urticarial vasculitis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10048820 Urticarial vasculitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000104-15 Sponsor Protocol Number: CCS1477-02 Start Date*: 2021-07-29
    Sponsor Name:CellCentric Ltd
    Full Title: An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with advanced haematological malignancies.
    Medical condition: Acute Myeloid Leukaemia (AML)/high-risk Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM) and Non-Hodgkin Lymphoma(NHL).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005991-41 Sponsor Protocol Number: OPTUK MSPP PRO002 Start Date*: 2007-03-12
    Sponsor Name:OptiNose UK Ltd.
    Full Title: A multicentre, double-blind, placebo-controlled evaluation of intranasal sumatriptan delivered with the OptiNose powder device in the treatment of acute migraine.
    Medical condition: Acute Treatment of Migraine with or without Aura
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027599 Migraine LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002849-38 Sponsor Protocol Number: AQ-PRO-005 Start Date*: 2020-09-08
    Sponsor Name:Aquilon Pharmaceuticals
    Full Title: A prospective, active-controlled, randomized, open label, single-center, multiple dose, two-period crossover clinical trial to assess the safety, pharmacodynamics, pharmacokinetics, and preliminary...
    Medical condition: asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10003555 Asthma bronchial LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (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: 2022-003559-32 Sponsor Protocol Number: CPO19001 Start Date*: 2023-03-16
    Sponsor Name:PharOS Pharmaceutical Oriented Services Single Member Ltd.
    Full Title: A Phase III Prospective, Randomized, Multicenter, Double-Blind, Placebo-controlled clinical study to evaluate the efficacy and safety of fixed dose combination (FDC) product Ibuprofen/Paracetamol/P...
    Medical condition: Temporary relief of cold and flu symptoms, i.e. mild to moderate pain, sore throat, fever and nasal congestion
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10009851 Cold LLT
    21.1 100000004867 10022009 Influenza-like symptoms LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000561-33 Sponsor Protocol Number: TOL-2 Start Date*: 2022-03-08
    Sponsor Name:TolerogenixX GmbH
    Full Title: An open, randomized-controlled, multi-center phase-II clinical trial of individualized immunosuppression with intravenously administered donor modified immune cells (MIC) compared to standard-of-ca...
    Medical condition: Living donor kidney transplantation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10023438 Kidney transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004397-22 Sponsor Protocol Number: MS100070-0087 Start Date*: 2021-08-06
    Sponsor Name:Merck Healthcare KGaA
    Full Title: Single-arm, multicenter Phase I/Ib study of avelumab + lenvatinib in children with primary CNS tumors
    Medical condition: Primary CNS tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065143 Malignant solid tumour LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002613-31 Sponsor Protocol Number: 009896QM Start Date*: 2015-04-27
    Sponsor Name:Queen Mary University of London
    Full Title: A Phase Ib/IIa study of AZD2014 in combination with Selumetinib in patients with advanced cancers.
    Medical condition: Triple-Negative Breast Cancer Non-squamous Small Cell Lung Cancer Squamous Cell Lung Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-004793-26 Sponsor Protocol Number: HPN217-3001 Start Date*: 2020-06-24
    Sponsor Name:Harpoon Therapeutics, Inc.
    Full Title: A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relapsed/Refractory Multiple Myeloma
    Medical condition: Relapsed/Refractory Multiple Myeloma (RRMM)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004798-17 Sponsor Protocol Number: CLGX818X2102 Start Date*: 2013-10-12
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: Phase II, Multi-center, Open-label Study of Single-agent LGX818 Followed by a Rational Combination With Agents After Progression on LGX818, in Adult Patients With Locally Advanced or Metastatic BRA...
    Medical condition: Locally Advanced or Metastatic BRAF V600 Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001800-74 Sponsor Protocol Number: NEPA-15-18 Start Date*: 2015-08-17
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A phase 3, multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260 mg/0.25 mg) combination for the prevention of chemo...
    Medical condition: nausea and vomiting in cancer patients receiving highly emetogenic therapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10036899 Prophylaxis against chemotherapy induced vomiting LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed) ES (Completed) PL (Completed) HR (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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