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Clinical trials for Primary metabolites

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    374 result(s) found for: Primary metabolites. Displaying page 8 of 19.
    EudraCT Number: 2016-001641-79 Sponsor Protocol Number: 64041575RSV2001(ALS-8176-505) Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, Viral Kinetics, and Pharmacokinetics of Orally Administer...
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002708-26 Sponsor Protocol Number: CRC341 Start Date*: 2017-06-28
    Sponsor Name:University of Surrey
    Full Title: A randomised double blind placebo controlled pilot trial of oxytocin efficacy in treating detoxified opioid dependent individuals
    Medical condition: Opioid dependence. The study will be investigating the efficacy of Syntocinon (oxytocin) on treating the withdrawal symptoms and cravings that opioid (e.g. almost always heroin) dependent individua...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10057379 Addiction relapse LLT
    20.0 100000004873 10001126 Addiction any drug LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003510-13 Sponsor Protocol Number: IRST174.08 Start Date*: 2013-05-07
    Sponsor Name:IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
    Full Title: A phase II non randomized study evaluating the role of Androgen Receptors as Targets for therapy of pre-treated post-menopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/A...
    Medical condition: pre-treated post-menopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/AR-positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-001672-22 Sponsor Protocol Number: 42847922ISM2002 Start Date*: 2015-08-11
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A randomized, placebo-controlled, 2-way crossover, double-blind study to evaluate the efficacy, safety and tolerability of JNJ-42847922 in subjects with insomnia disorder without psychiatric comorb...
    Medical condition: Insomnia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-002849-36 Sponsor Protocol Number: 39758979ARA2001 Start Date*: 2012-01-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Metho...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002790-94 Sponsor Protocol Number: 200828 Start Date*: 2020-09-16
    Sponsor Name:SLSO
    Full Title: The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density – A Single Dose Randomized, Double Blind, Placebo-Controlled Phase 2 Positron Emission Tomography Study
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10025462 Major depressive disorder, recurrent episode, unspecified degree LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000459-35 Sponsor Protocol Number: TMB01-301 Start Date*: Information not available in EudraCT
    Sponsor Name:Timber Pharmaceuticals, LLC
    Full Title: Protocol Title: The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - with a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (Xlinked) or ARC...
    Medical condition: Congenital ichthyosis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002625-29 Sponsor Protocol Number: GWSP19066 Start Date*: 2020-01-14
    Sponsor Name:GW Pharma Limited
    Full Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) GB (GB - no longer in EU/EEA) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-002802-30 Sponsor Protocol Number: GS-US-337-0124 Start Date*: 2014-03-12
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who ha...
    Medical condition: Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) IT (Completed) AT (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-001219-53 Sponsor Protocol Number: TR11 Start Date*: 2019-03-06
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRI...
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10037084 Prurigo nodularis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001653-40 Sponsor Protocol Number: 64041575RSV2003 Start Date*: 2016-12-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Re...
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended) SE (Prematurely Ended) NL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011217-24 Sponsor Protocol Number: E7389-E044-203 Start Date*: 2009-12-03
    Sponsor Name:Eisai Ltd
    Full Title: A Phase 1b/2, Multicenter, Open-label, Dose-escalation and Confirmation Study of Eribulin in Combination with Capecitabine
    Medical condition: Phase 1 - Advanced and/or metastatic cancer Phase 2 - Advanced and/or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027477 Metastatic carcinoma LLT
    17.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-002132-67 Sponsor Protocol Number: GWEP17005 Start Date*: 2021-10-22
    Sponsor Name:GW Research Ltd
    Full Title: An Open-Label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared with Standard of Care Antiseizure Medi...
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080584 Tuberous sclerosis complex PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-003876-38 Sponsor Protocol Number: EDP305-102 Start Date*: 2020-08-19
    Sponsor Name:Enanta Pharmaceuticals Inc.
    Full Title: A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH) (ARGON-2)
    Medical condition: Non-alcoholic Steatohepatitis (NASH)
    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: DE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-003017-25 Sponsor Protocol Number: PRV-6527-CD2a Start Date*: 2018-01-08
    Sponsor Name:Provention Bio, Inc.
    Full Title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-...
    Medical condition: Moderately to severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10011402 Crohn's disease (colon) LLT
    20.0 100000004856 10011403 Crohn's disease aggravated LLT
    20.1 100000004856 10058815 Crohn's disease acute episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) ES (Completed) PL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003625-42 Sponsor Protocol Number: GS-US-342-4062 Start Date*: 2017-03-24
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic HCV Infection Who are on Dialysis for End Stage Renal Di...
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    19.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-004814-24 Sponsor Protocol Number: 17SARC04 Start Date*: 2018-03-19
    Sponsor Name:INSTITUT CLAUDIUS REGAUD
    Full Title: Pharmacologic interaction between Ifosfamide and Aprepitant in treated patients with soft tissue sarcoma.
    Medical condition: Soft tissue sarcoma (localized, local recidive or metastatic)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075333 Soft tissue sarcoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001156-19 Sponsor Protocol Number: D9614C00007 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca LP
    Full Title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroeso...
    Medical condition: Pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017885 Gastrooesophageal reflux disease PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003272-12 Sponsor Protocol Number: 18-ICH-001 Start Date*: 2019-10-14
    Sponsor Name:Mayne Pharma LLC
    Full Title: A Phase 2 Randomized, Multi-center, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream...
    Medical condition: Lamellar ichthyosis (LI) Autosomal Recessive Ichthyosis with Lamellar Scale
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10023686 Lamellar ichthyosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001626-26 Sponsor Protocol Number: OMT28-C0201 Start Date*: 2019-01-23
    Sponsor Name:OMEICOS Therapeutics GmbH
    Full Title: A Placebo-controlled, double-blind, Randomized, dose finding phase II study on OMT-28 in MaIntenance of Sinus rhythm after Electrical cardioversion in patients with persistent Atrial Fibrillation (...
    Medical condition: Persistent atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BG (Completed) HU (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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