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Clinical trials for Clinical Formulation

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    776 result(s) found for: Clinical Formulation. Displaying page 1 of 39.
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    EudraCT Number: 2012-001611-23 Sponsor Protocol Number: V260-035 Start Date*: 2012-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, COntrolled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)
    Medical condition: Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) FI (Completed) CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-004442-25 Sponsor Protocol Number: CFAM810B2304 Start Date*: 2016-04-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A multicenter, open-label, single-arm, two-step study to evaluate the safety and single-dose pharmacokinetics of famciclovir and multiple-dose safety after administration of famciclovir oral pediat...
    Medical condition: Chickenpox Herpes Zoster
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004441-17 Sponsor Protocol Number: CFAM810B2303 Start Date*: 2016-04-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediat...
    Medical condition: Herpes Simplex
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004043-23 Sponsor Protocol Number: CoFu-01 Start Date*: 2020-07-23
    Sponsor Name:University Hospital Schleswig-Holstein (UKSH)
    Full Title: Cognitive function after liver transplantation comparing Tacrolimus formulations
    Medical condition: Immunosuppression post liver transplantation
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004865 10024716 Liver transplantation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000728-17 Sponsor Protocol Number: A2581174 Start Date*: 2012-02-13
    Sponsor Name:Pfizer Inc
    Full Title: An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing a Pediatric Appropriate Formulation to a 10 mg Commercial Atorvastatin Calcium Tablet Formulation in Healthy...
    Medical condition: pharmacokinetic
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000308-28 Sponsor Protocol Number: ICL670F1102 Start Date*: 2016-03-09
    Sponsor Name:Novartis
    Full Title: A randomized, open label, six sequences, cross-over study in healthy Japanese subjects to evaluate the pharmacokinetic comparability of deferasirox granule formulation with the reference dispersibl...
    Medical condition: Healthy adult subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000307-93 Sponsor Protocol Number: CICL670F2105 Start Date*: 2016-03-09
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: A randomized, open label, single center, phase I, two way, cross-over study to evaluate the pharmacokinetic comparability of deferasirox new granule formulation with the reference dispersible formu...
    Medical condition: Healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003239-61 Sponsor Protocol Number: 107876 Start Date*: 2006-09-29
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologic...
    Medical condition: Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2023-000381-34 Sponsor Protocol Number: CL019_168 Start Date*: 2023-05-30
    Sponsor Name:ChemoCentryx
    Full Title: An Open Label, Randomized, Crossover, Single Dose Bioavailability Study in Healthy Adult Subjects to Evaluate the Pharmacokinetic Profile of an Exploratory Avacopan Pediatric Liquid Formulation Com...
    Medical condition: Anti-Neutrophil Cytoplasmic Antibody associated vasculitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003876-42 Sponsor Protocol Number: SAKK38/19 Start Date*: 2022-04-29
    Sponsor Name:SAKK
    Full Title: Assessing a ctDNA and PET-oriented therapy in patients with DLBCL. A multicenter, open-label, phase II trial
    Medical condition: Disseminated large B cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10060580 Diffuse large cell lymphoma (Adult T-cell lymphoma/leukemia) (Working Formulation) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004901-25 Sponsor Protocol Number: MEK115892 Start Date*: 2012-07-25
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: An Open-Label, Two-Period, Randomized, Crossover Study to Assess the Relative Bioavailability of GSK1120212 Tablet Formulation and the GSK1120212 Pediatric Oral Solution Formulation Following Si...
    Medical condition: GSK1120212 is currently being developed for a number of solid tumors, including metastatic BRAF-mutant melanoma (Phase 3), pancreatic cancer (Phase 2) and non small cell lung cancer (Phase 2), and ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002853-77 Sponsor Protocol Number: TULIP Start Date*: 2011-10-20
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: PROSPECTIVE, RANDOMISED, CROSSOVER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE LIPID-LOWERING EFFECT OF ADDING TENOFOVIR/EMTRICITABINE CO-FORMULATION VS PLACEBO TO HIV-1-INFECTED SUBJECTS...
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-000278-13 Sponsor Protocol Number: P16-07/BP052 Start Date*: Information not available in EudraCT
    Sponsor Name:BIOPROJET PHARMA
    Full Title: Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulatio...
    Medical condition: Young healthy volunteers (7-12 years)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10055955 Acute diarrhoea LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-000554-46 Sponsor Protocol Number: 106786 Start Date*: 2006-08-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphth...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2012-000706-30 Sponsor Protocol Number: A2581175 Start Date*: 2012-02-09
    Sponsor Name:Pfizer Inc
    Full Title: An Open Label, Randomized, Single Dose, Two-Way Crossover bioequivalence Study Comparing a New 80 mg (2x40 mg) Pediatric Appropriate Formulation to an 80 mg Commercial Atorvastatin Calcium Tablet F...
    Medical condition: pharmacokinetic trial
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023485-53 Sponsor Protocol Number: IJG-PAR-2010 Start Date*: 2011-04-20
    Sponsor Name:IDIAP JORDI GOL I GURINA
    Full Title: Evaluation of the relationship between effervescent acetaminophen and blood pressure. A clinical trial.
    Medical condition: Evaluation of whether paracetamol effervescent formulation increases blood pressure compared with effervescent paracetamol formulation does not
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-006481-21 Sponsor Protocol Number: 79916 Start Date*: 2022-09-08
    Sponsor Name:Erasmus MC - Sophia Kinderziekenhuis
    Full Title: Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation
    Medical condition: Renal transplant recipients
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002258-22 Sponsor Protocol Number: 209141 Start Date*: 2019-11-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase II randomized, observer-blind, placebo-controlled, multi-country study in healthy non-pregnant women 18-45 years of age to evaluate the safety, reactogenicity and immunogenicity of a 1st intr...
    Medical condition: Healthy Volunteers (prevention of lower respiratory tract illness)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-001511-30 Sponsor Protocol Number: 2-55-52014-145 Start Date*: 2006-10-26
    Sponsor Name:Beaufour Ipsen Pharma
    Full Title: A phase III, single arm, multicentre study to evaluate the efficacy and safety of a subcutaneous four-month sustained-release formulation of triptorelin, a gonadotrophin releasing hormone analogue ...
    Medical condition: Locally advanced or metastatic prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) GB (Prematurely Ended) FR (Completed) PT (Completed) LV (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003727-10 Sponsor Protocol Number: MO40598 Start Date*: 2019-12-16
    Sponsor Name: Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd
    Full Title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-G...
    Medical condition: Relapsed/refractory diffuse large B-cell lymphoma (DLBL)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10012857 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory LLT
    21.1 100000004864 10012856 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent LLT
    21.0 100000004864 10012855 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing) GB (GB - no longer in EU/EEA) IE (Completed) FI (Completed) SE (Completed) IT (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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