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Clinical trials for Acceptable daily intake

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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    79 result(s) found for: Acceptable daily intake. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2019-001384-68 Sponsor Protocol Number: TMC114FD2HTX1006 Start Date*: 2019-09-19
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Study to Assess the Acceptability of Scored Film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Parti...
    Medical condition: Human Immunodeficiency Virus Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-001098-26 Sponsor Protocol Number: MK-7264-034 Start Date*: 2018-09-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2a, Proof of Concept, Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women with Moderate to Severe Endometriosis-related Pain
    Medical condition: Moderate to severe Endometriosis-related pain (ERP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10014788 Endometriosis related pain LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-017351-96 Sponsor Protocol Number: baclofen2009 Start Date*: 2009-12-23
    Sponsor Name:UZleuven
    Full Title: A placebo controlled trial with Baclofen for the treatment of GERD patients with incomplete PPI response
    Medical condition: Gastroesophageal reflux disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004519-35 Sponsor Protocol Number: PANC2002 Start Date*: 2015-01-09
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreat...
    Medical condition: Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002629-36 Sponsor Protocol Number: SP1047 Start Date*: 2014-08-06
    Sponsor Name:UCB Biosciences, Inc
    Full Title: A multicenter, open-label study to investigate the pharmacokinetics of commercial lacosamide oral formulation as therapy in children (aged 1 month to 17 years) with epilepsy.
    Medical condition: Epilepsy
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-002145-21 Sponsor Protocol Number: 2007003 Start Date*: 2007-12-21
    Sponsor Name:Procter & Gamble Pharmaceuticals
    Full Title: A Phase II, Randomized, Placebo-controlled Study of ATI-7505 in Patients with Chronic Idiopathic Constipation
    Medical condition: Chronic Idiopathic Constipation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063582 Constipation chronic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002125-35 Sponsor Protocol Number: SMR-2591 Start Date*: 2014-12-18
    Sponsor Name:Algipharma AS
    Full Title: A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization ...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003739-57 Sponsor Protocol Number: 11613A Start Date*: 2007-01-18
    Sponsor Name:H. Lundbeck A/S
    Full Title: A double-blind, randomised, parallel-group, placebo-controlled study investigating the safety- and tolerability following fixed oral dose regimens (daily versus twice weekly administration) of Lu 3...
    Medical condition: Lu 31-130 is under development by H. Lundbeck A/S as an antipsychotic in treatment of schizophrenia.
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000374-60 Sponsor Protocol Number: N01266 Start Date*: 2011-07-05
    Sponsor Name:UCB Pharma SA
    Full Title: OPEN-LABEL, SINGLE-ARM, MULTICENTER, LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC SUBJECTS WITH EPILEPSY
    Medical condition: Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) ES (Completed) PL (Completed) Outside EU/EEA IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) NL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000168-22 Sponsor Protocol Number: SIK-FR-22-1 Start Date*: Information not available in EudraCT
    Sponsor Name:Addmedica
    Full Title: An open-label, non-comparative, multicentre study to evaluate the acceptability of a new paediatric formulation of hydroxycarbamide in children with sickle cell disease
    Medical condition: Drepanocytosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10051835 Drepanocytosis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-005365-11 Sponsor Protocol Number: KF5303/01 Start Date*: 2006-03-31
    Sponsor Name:Grünenthal GmbH
    Full Title: A randomised, 2-arm, parallel group study assessing efficacy and tolerability of titrated transdermal buprenorphine in patients with moderate to severe chronic non malignant pain
    Medical condition: Moderate to severe chronic pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2016-002611-18 Sponsor Protocol Number: KF7019-01 Start Date*: 2017-04-27
    Sponsor Name:Grünenthal GmbH
    Full Title: An exploratory, randomized, double-blind, double-dummy, placebo- and active-controlled Phase II trial to evaluate the efficacy and safety of a topical application of GRT7019 in subjects with chroni...
    Medical condition: osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-002003-28 Sponsor Protocol Number: 53718678RSV1005 Start Date*: 2015-11-04
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants ho...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) ES (Prematurely Ended) NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003206-41 Sponsor Protocol Number: TAK-954-2002 Start Date*: 2018-05-29
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Int...
    Medical condition: A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Int...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10074293 Enteral feeding intolerance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006686-17 Sponsor Protocol Number: P05094 Start Date*: 2007-04-25
    Sponsor Name:Schering-Plough
    Full Title: Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent...
    Medical condition: For both compounds, substitution treatment for opiod drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intrav...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-021860-13 Sponsor Protocol Number: BIA-91067-301 Start Date*: 2010-11-11
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH “WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMIS...
    Medical condition: Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) AT (Completed) LV (Completed) DE (Completed) ES (Completed) PT (Completed) CZ (Completed) SK (Completed) BG (Completed) RO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000827-42 Sponsor Protocol Number: N01372 Start Date*: 2012-09-27
    Sponsor Name:UCB Pharma SA
    Full Title: AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH EPILEPSY
    Medical condition: Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001264-28 Sponsor Protocol Number: P2-IMU-838-COV Start Date*: 2020-05-28
    Sponsor Name:Immunic AG
    Full Title: A Prospective, Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator’s Choice of Standard of Ca...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) RO (Completed) GR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2021-001866-39 Sponsor Protocol Number: NOE-TGN-201 Start Date*: 2022-02-24
    Sponsor Name:Noema Pharma
    Full Title: A Phase II/III, multicentre, 8-week run-in phase followed by a 12- week, prospective, parallel-group, double-blind, randomized withdrawal, placebo-controlled study, with a 52 week open label exten...
    Medical condition: Trigeminal neuralgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10044652 Trigeminal neuralgia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001316-35 Sponsor Protocol Number: KF6005/07 Start Date*: 2012-12-20
    Sponsor Name:Grünenthal GmbH
    Full Title: Efficacy, safety, and tolerability of oral Cebranopadol versus morphine sulphate PR in subjects with chronic moderate to severe pain related to cancer.
    Medical condition: The trial population, comprising patients with cancer pain requiring WHO Step III analgesics, will represent the typical population suffering from cancer-related pain. Patient having various types ...
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Prematurely Ended) HU (Completed) SE (Completed) ES (Completed) SK (Completed) PL (Completed) NL (Completed) AT (Completed) DK (Completed) BG (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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