Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Equivalence point

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    30 result(s) found for: Equivalence point. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-002279-27 Sponsor Protocol Number: DICL001 Start Date*: 2014-10-28
    Sponsor Name:Hi-Tech Pharmacal Co., Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) wi...
    Medical condition: osteoarthritis of the knee
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) LT (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-007018-39 Sponsor Protocol Number: Persephone Start Date*: 2007-08-09
    Sponsor Name:Cambridge Hospitals NHS Foundation Trust and Cambridge University
    Full Title: Persephone : Duration of Trastuzumab with Chemotherapy in patients with early breast cancer : Six months versus twelve
    Medical condition: HER2 positive early breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-022905-17 Sponsor Protocol Number: GWCA1103 Start Date*: 2011-12-26
    Sponsor Name:GW Pharma Ltd.
    Full Title: A two-part, placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patien...
    Medical condition: Pain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.
    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: ES (Completed) IT (Completed) GB (Completed) LT (Completed) PL (Completed) DE (Completed) HU (Completed) RO (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-007161-20 Sponsor Protocol Number: BK0023-02C Start Date*: 2009-01-08
    Sponsor Name:BIO-KER S.R.L
    Full Title: Comparable efficacy and safety profiles of daily injection of BK0023 and filgrastim (Neupogen®) in chemotherapy-induced neutropenia: a multinational, multicenter, investigator blind, randomised, pa...
    Medical condition: Chemotherapy induced Neutropenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029354 Neutropenia LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002970-32 Sponsor Protocol Number: KKL072012 Start Date*: 2013-12-23
    Sponsor Name:KRKA, tovarna zdravil, d. d., Novo mesto
    Full Title: A COMPARISON OF THERAPEUTIC EQUIVALENCE BETWEEN THE TEST AND THE REFERENCE FORMULATION OF FIXED COMBINATION OF CETYLPYRIDINIUM CHLORIDE 1.0 mg/BENZYDAMINE HYDROCHLORIDE 3 mg IN SUBJECTS WITH SORE T...
    Medical condition: Sore throat associated with upper respiratory infections
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10041368 Sore throat NOS LLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10068319 Oropharyngeal pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2020-004167-29 Sponsor Protocol Number: NA Start Date*: 2021-03-15
    Sponsor Name:CHU de Liège
    Full Title: Study of the noninferiority of an oral versus intravenous administration of tranexamic acid in total hip arthroplasty
    Medical condition: Bleeding in total hip arthroplasty
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-006069-15 Sponsor Protocol Number: Gebro-III-28-2 Start Date*: 2006-05-19
    Sponsor Name:Gebro Pharma GmbH
    Full Title: Population pharmacokinetic/pharmacodynamic and tolerability clinical trial in patients suffering from acute post-operative pain
    Medical condition: pharmakodynamik: Acute post-operative pain after an operation (surgery) (acute is defined as within 4 hours after end of surgery). pharmakokinetik: Acute post-operative pain is not necessary. Tria...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10054711 LLT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-000780-42 Sponsor Protocol Number: Latanoprost 1/2007 Start Date*: 2008-02-20
    Sponsor Name:PH&T SPA
    Full Title: Evaluation of the therapeutic equivalence of latanoprost PK and Xalatan. Double blind randomized clinical trial in subjects affected by open angle glaucoma or intraocular hypertension.
    Medical condition: Subjects affected by glaucoma or intraocular hypertension.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015919 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004476-30 Sponsor Protocol Number: V72_41 Start Date*: 2014-10-24
    Sponsor Name:Novartis Vaccines and Diagnostics SRL
    Full Title: A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactu...
    Medical condition: Prophylaxis against invasive meningococcal disease
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004888-31 Sponsor Protocol Number: OXN3508 Start Date*: 2015-01-26
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, double-dummy, cross-over multicenter study to demonstrate equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as ...
    Medical condition: The intended indication is: Chronic severe non malignant pain, chronic severe malignant pain, requiring opioids.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005419-10 Sponsor Protocol Number: TRAVOPROSTPR1/2011 Start Date*: 2012-02-29
    Sponsor Name:PH&T SPA
    Full Title: EVALUATION OF THE THERAPEUTIC EQUIVALENCE OF TRAVOPROST PR AND TRAVATAN. DOUBLE BLIND RANDOMIZED CLINICAL TRIAL IN SUBJECTS AFFECTED BY GLAUCOMA OR INTRAOCULAR HYPERTENSION.
    Medical condition: Primary open angle glaucoma (POAG) or ocular hypertension (OH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10015919 Eye disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005396-17 Sponsor Protocol Number: MRZ 60201-0617/1 Start Date*: 2007-05-30
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: A prospective, randomized, double-blinded, international multicenter trial to investigate the efficacy and safety of NT 201 in comparison to placebo and to compare two different application schemes...
    Medical condition: Treatment of lateral periorbital wrinkles ("Crow's feet")
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052611 Crow's feet LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-000078-19 Sponsor Protocol Number: CH/2006/2401 Start Date*: 2009-03-25
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation
    Medical condition: Patients must be admitted to PICU and are likely to require intubation and ventilation for more than 48 hours.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039897 Sedation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-000913-35 Sponsor Protocol Number: BECRO/OV/DORZO Start Date*: 2019-05-21
    Sponsor Name:BECRO (Cyprus) Ltd
    Full Title: A Randomized, Observer-blind, two Parallel Group, Multi-center, Clinical Trial for Comparing the Efficacy and Tolerability of Dorzo-Vision® sine Preservative-Free Eye Drops vs. Trusopt® Preservativ...
    Medical condition: Open angle glaucoma or ocular hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    20.0 10015919 - Eye disorders 10030348 Open angle glaucoma PT
    20.0 10015919 - Eye disorders 10030043 Ocular hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001947-23 Sponsor Protocol Number: PEL01CVH Start Date*: 2007-11-28
    Sponsor Name:HELP Pharmaceuticals S.A.
    Full Title: A multicenter, randomized, parallel patients’ group, comparative clinical trial for the assessement of efficacy and safety of Pelethrocin®/HELP 500 mg (generic diosmin & hesperidin MPFF) versus Daf...
    Medical condition: Chronic Venous Insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066682 Chronic venous insufficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010968-42 Sponsor Protocol Number: DGD-44-045 Start Date*: 2009-07-07
    Sponsor Name:GUERBET
    Full Title: Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases
    Medical condition: Patient suffering from abdominal or lower limb arterial diseases
    Disease: Version SOC Term Classification Code Term Level
    9.1 10062585 Peripheral arterial occlusive disease LLT
    9.1 10062585 Peripheral arterial occlusive disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001660-30 Sponsor Protocol Number: CHL.3/01-2019/M Start Date*: 2020-06-03
    Sponsor Name:Sintetica S.A.
    Full Title: A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemuls...
    Medical condition: cataract surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10063797 Cataract operation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005327-16 Sponsor Protocol Number: Start Date*: 2014-07-15
    Sponsor Name:The University of Edinburgh [...]
    1. The University of Edinburgh
    2. NHS Lothian
    Full Title: A Randomized Open Label Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function after Colorectal Surgery
    Medical condition: Post-operative pain
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10036236 Postoperative pain relief LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-000079-18 Sponsor Protocol Number: PHN-BBFC-NI101 Start Date*: 2020-03-18
    Sponsor Name:Pharmathen S.A.
    Full Title: A phase III, multicentre, prospective, randomized, assessor-blinded, two-arm, parallel group, therapeutic non-inferiority 3-month clinical trial to compare the efficacy and safety of a generic fixe...
    Medical condition: Open-angle glaucoma (OAG) or ocular hypertension (OHT)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    20.0 10015919 - Eye disorders 10030348 Open angle glaucoma PT
    20.0 10015919 - Eye disorders 10030043 Ocular hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-003111-22 Sponsor Protocol Number: V98_21 Start Date*: 2014-11-06
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyop...
    Medical condition: Healthy person immune response to Group B Streptococcus polysaccharide capsule antigens
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10053588 Group B streptococcus neonatal sepsis PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) CZ (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Jun 11 00:11:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA