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Clinical trials for Granules

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   44335   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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    386 result(s) found for: Granules. Displaying page 1 of 20.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2012-004178-24 Sponsor Protocol Number: RP-OSV-02-D Start Date*: 2013-12-27
    Sponsor Name:Fresenius Medical Care Deutschland GmbH
    Full Title: Study to investigate the therapeutic equivalence of OsvaRen® tablets and OsvaRen® granules
    Medical condition: Hyperphosphataemia in end stage renal failure patients on extracorporeal renal replacement therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015158-39 Sponsor Protocol Number: SAG-51/DIV Start Date*: 2010-05-06
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, dose-response, randomised, placebo-controlled, parallel group, multicentre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevent...
    Medical condition: Diverticulitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10013538 Diverticulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FI (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004392-41 Sponsor Protocol Number: MK-1439A-054 Start Date*: 2016-11-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Comparative Bioavailability of Two Investigational Pediatric Oral Granule Formulations of Lamivudine and Tenofovir Compared to the Adult Marketed Formulations. Other PIP decision ...
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001026-22 Sponsor Protocol Number: 1813T0835 Start Date*: 2021-03-05
    Sponsor Name:Shionogi & Co., Ltd.
    Full Title: An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patient...
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004534-40 Sponsor Protocol Number: 3001B3-329-WW Start Date*: 2007-03-06
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WI...
    Medical condition: Treatment of gastroesophageal reflux disease (GERD) symptoms in infants 1 through 11 months
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) LV (Completed) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2004-001216-31 Sponsor Protocol Number: SAG-26/UCA Start Date*: 2005-05-30
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in...
    Medical condition: Therapy of active ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058816 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SK (Completed) HU (Completed) LV (Completed) CZ (Completed) EE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2020-001961-34 Sponsor Protocol Number: RDG-1/PBC Start Date*: 2021-02-02
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis
    Medical condition: Primary biliary cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) HU (Prematurely Ended) SK (Prematurely Ended) NL (Prematurely Ended) BE (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006198-26 Sponsor Protocol Number: SAG-44/DIV Start Date*: 2007-07-23
    Sponsor Name:University of Nottingham
    Full Title: Mechanistic randomised contorlled trial of Mesalazine in symptomatic diverticular disease
    Medical condition: Symptomatic diverticular disease defines as patients with recurrent abdominal pain on more then 3 days per month with proven diverticula.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000680-22 Sponsor Protocol Number: SAG-37/DIV Start Date*: 2007-10-29
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurre...
    Medical condition: Diverticultits
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013538 Diverticulitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) NL (Completed) LV (Completed) LT (Completed) SK (Completed) EE (Completed) GB (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000962-76 Sponsor Protocol Number: 17992 Start Date*: 2015-09-22
    Sponsor Name:Bayer AG
    Full Title: Single-dose study testing a rivaroxaban granules for oral suspension formulation in children from 2 months to 12 years with previous thrombosis
    Medical condition: Thrombosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10043607 Thrombosis PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) IE (Completed) ES (Completed) FI (Completed) HU (Completed) SE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001474-24 Sponsor Protocol Number: 3001B3–335-WW Start Date*: 2006-08-07
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
    Full Title: A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD
    Medical condition: INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2004-001218-15 Sponsor Protocol Number: SAG-27/UCR Start Date*: 2005-04-04
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granule...
    Medical condition: Maintenance therapy of ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SK (Completed) HU (Completed) EE (Completed) LV (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2020-000689-40 Sponsor Protocol Number: VX19-661-012 Start Date*: 2020-02-25
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healt...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005374-26 Sponsor Protocol Number: ECAELEV21 Start Date*: 2022-08-18
    Sponsor Name:OMEQUI coordinator
    Full Title: Efficacy of platelet- and leukocyte-rich fibrin (L-PRF) in reducing healing time in sinus lift combined with deproteinized bovine mineralized bone (DBBM): randomized clinical trial.
    Medical condition: If the application of L-PRF with respect to the use of DBBM shows that there are differences in the percentage of new bone between the LPRF group and the control group at 4 and 6 months
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002350-68 Sponsor Protocol Number: F506-CL-0405 Start Date*: 2022-10-12
    Sponsor Name:Astellas Pharma China, Inc.
    Full Title: A Multicenter, Open-label, Non-comparative Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidne...
    Medical condition: liver and kidney transplantation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-004159-39 Sponsor Protocol Number: BUC-60/COC Start Date*: 2007-03-15
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules vs. mesalazine granules vs. placebo for pat...
    Medical condition: Collagenous colitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10048928 Colitis collagenous PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) LT (Completed) DK (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000648-16 Sponsor Protocol Number: BAY59-7939/19365 Start Date*: 2017-06-21
    Sponsor Name:Bayer AG
    Full Title: Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 10 mg granules for oral suspension rivaroxaban versus 10 mg tablets rivaroxaban under fasted condition in healthy subjects
    Medical condition: Prevention and treatment of thromboembolic disorders
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10043640 Thrombosis venous LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000609-18 Sponsor Protocol Number: BAY59-7939/19366 Start Date*: 2017-06-20
    Sponsor Name:Bayer AG
    Full Title: Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 20 mg granules for oral suspension rivaroxaban versus 20 mg tablets rivaroxaban under fed condition in healthy subjects
    Medical condition: Prevention and treatment of thromboembolic disorders
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10043640 Thrombosis venous LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005499-33 Sponsor Protocol Number: HP5503-88 Start Date*: 2014-11-11
    Sponsor Name:Grünenthal GmbH
    Full Title: Relative bioavailability trial to investigate the pharmacokinetics of tapentadol following the administration of 3 prototype tapentadol 25 mg prolonged release (PR) granule formulations compared to...
    Medical condition: No medical condition to be investigated.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2023-001004-33 Sponsor Protocol Number: CLCZ696B2319E2 Start Date*: 2025-01-20
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Safety Study of Sacubitril/​Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
    Medical condition: Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10019280 Heart failures HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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