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Clinical trials for Over-the-counter drugs

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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    35 result(s) found for: Over-the-counter drugs. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-001070-29 Sponsor Protocol Number: CRF005 Start Date*: 2023-05-26
    Sponsor Name:Chelsea and Westminster NHS Foundation Trust
    Full Title: Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)
    Medical condition: Human Immunodeficiency Virus (HIV) infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10020441 Human immunodeficiency virus infection, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001284-20 Sponsor Protocol Number: BIOGIO Start Date*: 2017-07-05
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: The effects of the proton pump inhibitor esomeprazole on the bioavailability of afatinib (Giotrif®) in patients with non-small cell lung cancer (NSCLC) 'the BIO-GIO study'
    Medical condition: Non small cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005784-17 Sponsor Protocol Number: REGORA Start Date*: 2016-05-19
    Sponsor Name:Erasmus MC cancer institute
    Full Title: The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).
    Medical condition: GIST and mCRC patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015796-27 Sponsor Protocol Number: SMA-09-18 Start Date*: 2009-11-12
    Sponsor Name:Alcon d.o.o.
    Full Title: Patient Preference Comparison of Azarga versus Cosopt, after Single Doses in Patients with Open-Angled Glaucoma or Ocular Hypertension
    Medical condition: Open-angle glaucoma or ocular hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2016-003575-21 Sponsor Protocol Number: Start Date*: 2017-07-25
    Sponsor Name:MRC Clinical Trials Unit at UCL
    Full Title: A multicentre, 48 week randomised controlled factorial trial of adding maraviroc and/or metformin for hepatic steatosis in HIV-1-infected adults on combination antiretroviral therapy.
    Medical condition: Hepatic steatosis in adults with chronic HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004871 10029530 Non-alcoholic fatty liver LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2006-005967-25 Sponsor Protocol Number: BVT.115959-005 Start Date*: 2007-03-06
    Sponsor Name:Biovitrum AB
    Full Title: A double-blind, placebo-controlled, randomized, parallel-group study evaluating the efficacy and tolerability of oral BVT.115959, a novel A2A agonist, versus placebo in the treatment of diabetic ne...
    Medical condition: Diabetic Neuropathic Pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024244-15 Sponsor Protocol Number: RDG-10-251 Start Date*: 2011-07-01
    Sponsor Name:ALCON Research Ltd
    Full Title: "Patient Preference Comparison of Azarga versus Cosopt, in Patients with Open-Angle Glaucoma or Ocular Hypertension."
    Medical condition: Open-Angle Glaucoma and Ocular Hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10018307 Glaucoma and ocular hypertension HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023311-34 Sponsor Protocol Number: CPA 368-10 Start Date*: 2011-02-04
    Sponsor Name:AOP Orphan Pharmaceuticals AG
    Full Title: A prospective, randomized, double blinded, crossover, two-treatment, two-sequence, short term pharmacokinetic, pharmacodynamic and tolerability, single centre study to compare AOP200704 vs. Esmolol...
    Medical condition: healthy male and female volunteers, intended for the treatment of dobutamine-induced tachycardia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10040752 Sinus tachycardia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-005269-66 Sponsor Protocol Number: BAYH6689/13130 Start Date*: 2015-02-09
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Den...
    Medical condition: Toothache
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10044049 Dental pain and sensation disorders HLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004465-27 Sponsor Protocol Number: COCA Start Date*: 2018-02-01
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: The effects of the proton pump inhibitor esomeprazole alone or in combination with Coca-Cola on the absorption of Capecitabine in patients with colorectal cancer or other solid tumours ' the COCA s...
    Medical condition: Colorectal carcinoma or other solid tumours
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004670-24 Sponsor Protocol Number: SYR-322-PLC-010 Start Date*: 2006-05-26
    Sponsor Name:Takeda Global Research & Development Center, Inc.
    Full Title: A multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and safety of SYR110322 (SYR-322) Compared with Placebo in Subjects with Type 2 Diabetes
    Medical condition: Type II diabetes mellitus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-002711-25 Sponsor Protocol Number: 039SC04253 Start Date*: 2005-08-01
    Sponsor Name:ANGELINI
    Full Title: DOSE-FINDING STUDY OF TRAZODONE IN THE TREATMENT OF PATIENTS WITH PRIMARY INSOMNIA
    Medical condition: TREATMENT OF THE INSOMNIA
    Disease: Version SOC Term Classification Code Term Level
    6.1 10022437 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-000881-22 Sponsor Protocol Number: M10-336 Start Date*: 2008-07-17
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400...
    Medical condition: Treatment-naïve, HIV-1 infected subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020162 HIV infection CDC Group I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000694-30 Sponsor Protocol Number: 01-05-TL-322OPI-001 Start Date*: 2006-09-21
    Sponsor Name:Takeda Europe Research & Development Centre Ltd.,
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS) in Subjects with Type ...
    Medical condition: Type II Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2005-001430-32 Sponsor Protocol Number: M05-730 Start Date*: 2005-11-18
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Open-label, Study of Lopinavir/ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, when Coadministered with NRTIs in Antiretroviral N...
    Medical condition: HIV-1 infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) CZ (Completed) BE (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002380-26 Sponsor Protocol Number: Somagel Start Date*: 2018-09-13
    Sponsor Name:SOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
    Full Title: Single-group, open study on the systemic bioavailability, safety and local tolerability of a new gel formulation of Somatoline¿ in 30 healthy women.
    Medical condition: Edematous fibrosclerotic panniculopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005278-12 Sponsor Protocol Number: BAY1019036/15082 Start Date*: 2015-02-09
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain
    Medical condition: postsurgical (extraction) dental pain
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10044049 Dental pain and sensation disorders HLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004669-40 Sponsor Protocol Number: SYR-322-TZD-009 Start Date*: 2006-03-15
    Sponsor Name:Takeda Global Research & Development Center, Inc.,
    Full Title: A multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and safety of SYR110322 (SYR-322) When Used in Combination with Pioglitazone in Subjects with Type 2 Diab...
    Medical condition: Type II diabetes mellitus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-004668-22 Sponsor Protocol Number: SYR-322-MET-008 Start Date*: 2006-05-26
    Sponsor Name:Takeda Global Research & Development Center, Inc.
    Full Title: A multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and safety of SYR110322 (SYR-322) When Used in Combination with Metformin in Subjects with Type 2 Diabetes
    Medical condition: Type II diabetes mellitus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-000748-14 Sponsor Protocol Number: M06-802 Start Date*: 2006-08-14
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhib...
    Medical condition: Antiretroviral experienced, HIV-1 Infection. Adequate ICD classification code not available.
    Disease: Version SOC Term Classification Code Term Level
    9.0 10020192 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) DE (Completed) IE (Completed) PT (Completed) GR (Completed) IT (Completed) GB (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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