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Clinical trials for Ambroxol

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   44364   clinical trials with a EudraCT protocol, of which   7388   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 ).  
     
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    11 result(s) found for: Ambroxol. Displaying page 1 of 1.
    EudraCT Number: 2021-002550-82 Sponsor Protocol Number: NL76160.018.21 Start Date*: 2022-12-22
    Sponsor Name:Amsterdam UMC
    Full Title: Effectiveness of ambroxol in children and adults with Gaucher disease 3: n-of-1 series
    Medical condition: Gaucher disease type 3
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027424 Metabolic and nutritional disorders congenital HLGT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005291-41 Sponsor Protocol Number: BIOC/AMBV/906 Start Date*: 2006-11-16
    Sponsor Name:CYATHUS Exquirere PharmaforschungsGmbH
    Full Title: A single center, open, pilot study to evaluate the pharmacokinetic profile of a new galenic formulation of an Ambroxol-Hydrochloride (Ambroxol-HCl) spray: Ambroxol “CYATHUS” 50 mg/mL Oral Spray, ad...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    8.1 10006440 Bronchial obstruction LLT
    Population Age: Adults Gender: Male
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-001833-38 Sponsor Protocol Number: 77347 Start Date*: 2023-04-20
    Sponsor Name:University Medical Center Groningen
    Full Title: The Dutch Parkinson GBA Ambroxol trial (DUPARG-AMBROXOL): A randomised, double-blind, placebo-controlled, single-center trial with Ambroxol in Parkinson patients with a GBA mutation.
    Medical condition: Parkinson's disease with a GBA1 mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002571-24 Sponsor Protocol Number: 15/0118 Start Date*: 2016-10-14
    Sponsor Name:Joint Research Office
    Full Title: A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Diseas...
    Medical condition: Parkinson disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003980-36 Sponsor Protocol Number: IIT15419 Start Date*: 2018-01-26
    Sponsor Name:Hull and East Yorkshire Hospitals NHS Trust
    Full Title: A single-Centre, open-label, exploratory study of the effect of 20 mg ambroxol hydrochloride on cough reflex sensitivity in patients with acute cough.
    Medical condition: acute cough assouciated with URTI
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10066522 Acute cough LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-004565-13 Sponsor Protocol Number: GR-2018-12366771 Start Date*: 2022-09-08
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: Ambroxol as a disease-modifying treatment to reduce the risk of cognitive impairment in GBA-associated Parkinson's disease. A multicenter, randomized, double-blind, placebo-controlled, phase 2 trial.
    Medical condition: Parkinson's disease associated to mutation on the GBA1 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10042832 Syndrome Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004377-44 Sponsor Protocol Number: Ambroxpall Start Date*: 2021-08-24
    Sponsor Name:Med. Univ. Wien, Innere Med. I, Abt. f. Palliativmedizin
    Full Title: Ambroxol inhalation for mucus clearance in palliative care patients - a randomized placebo-controlled double-blind pilot study.
    Medical condition: cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006224-40 Sponsor Protocol Number: AxGD Start Date*: Information not available in EudraCT
    Sponsor Name:Instytut ,,Pomnik-Centrum Zdrowia Dziecka"
    Full Title: Evaluation of the safety and efficacy of ambroxol (ABX) use in Polish patients with Gaucher disease, presenting neuronopathic type (GD type III, GD3) resulting from homozygous c.1448T>C mutation (p...
    Medical condition: Gaucher disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002855-41 Sponsor Protocol Number: ANeED Start Date*: 2021-01-12
    Sponsor Name:Helse Fonna
    Full Title: A phase IIa multicentre randomized controlled double blind clinical trial to demonstrate clinical efficacy on cognitive, neuropsychiatric and functional outcomes of Ambroxol in New and Early patien...
    Medical condition: Dementia with Lewy Bodies (DLB) and mild cognitive impairment (MCI) due to Lewy Body Disease (DLB-MCI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10067889 Dementia with Lewy bodies PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021422-35 Sponsor Protocol Number: 09-NI-EP-001 Start Date*: 2010-10-26
    Sponsor Name:Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
    Full Title: Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms. A randomized, international, multicen...
    Medical condition: Diagnosed upper respiratory tract infection (URTI) with presence of the following symptoms for equal or less than for 24 hours : a)Fever (axillary temperature >= 37.5°C) and b)At least one upper ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10046734 URTI (upper respiratory tract infection) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-001435-63 Sponsor Protocol Number: NACFL-ZI-L-01-06 Start Date*: 2008-01-28
    Sponsor Name:ZAMBON ITALIA
    Full Title: AEROSOLIC TREATMENT OF ACUTE AND RECURRENT RHINOSINUSITIS DURING INTERCRITICAL STAGES : SINGLE BLIND CLINICAL STUDY, N-ACETYLCISTEIN VS AMBROXOL, ASSOCIATED WITH CORTISONE THERAPY
    Medical condition: Patients with acute recurrent rhinosinusitis(intercritical stages)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001076 Acute sinusitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (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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