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Clinical trials for Esophageal pH monitoring

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   44334   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 ).  
     
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    15 result(s) found for: Esophageal pH monitoring. Displaying page 1 of 1.
    EudraCT Number: 2012-001160-29 Sponsor Protocol Number: SH-NEC-0002 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca AB
    Full Title: An Open Single-centre Study on the Pharmacokinetics and Pharmacodynamics of Esomeprazole After Once Daily Oral Administration for 7 Days in Preterm Infants and Neonates
    Medical condition: Gastraesdophageal Reflux Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10018203 GERD LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001159-37 Sponsor Protocol Number: SH-NEC-0001 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca AB
    Full Title: A Single-Blind, Randomised, Parallel-Group, Single-Centre Pharmacokinetic and pH-Monitoring Study of Esomeprazole in Infants up to 24 Months of Age
    Medical condition: Gastroesophageal Reflux Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10018203 GERD LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004175-31 Sponsor Protocol Number: Prucalopride2017 Start Date*: 2018-04-09
    Sponsor Name:TARGID, KU Leuven
    Full Title: A placebo-controlled trial with prucalopride for the treatment of typical reflux symptoms in patients with gastro-esophageal reflux disease with incomplete proton pump inhibitor response
    Medical condition: refractory gastro-esophageal reflux disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-013080-19 Sponsor Protocol Number: 27538 Start Date*: 2010-03-31
    Sponsor Name:AMC
    Full Title: Prokinetics to alter the position of the gastric acid pocket in Gastro Esophageal Reflux Disease
    Medical condition: gastro-esophageal reflux disease (GERD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000479 Acid reflux (oesophageal) LLT
    9.1 10017884 Gastrooesophageal reflux LLT
    9.1 10017885 Gastrooesophageal reflux disease LLT
    9.1 10038262 Reflux esophagitis LLT
    9.1 10020024 Hiatal hernia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-002001-31 Sponsor Protocol Number: D9614C00004 Start Date*: 2006-10-27
    Sponsor Name:AstraZeneca AB
    Full Title: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients,...
    Medical condition: This prospective study will evaluate the efficacy and safety of esomeprazole for the treatment of GERD in neonatal patients.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10017885 Gastrooesophageal reflux disease LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021397-12 Sponsor Protocol Number: M0003-C202 Start Date*: 2010-11-23
    Sponsor Name:Shire-Movetis NV
    Full Title: An explorative, randomized, placebo-controlled, double-blind, parallel-group trial, to evaluate the pharmacodynamic effect of M0003 on reflux parameters in subjects with gastroesophageal reflux dis...
    Medical condition: Gastrointestinal esophageal reflux disease (GERD) refractory to proton pump inhibitor therapy
    Disease: Version SOC Term Classification Code Term Level
    12.1 10017885 Gastrooesophageal reflux disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) DE (Prematurely Ended) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-003067-46 Sponsor Protocol Number: FZ07/04 Start Date*: 2007-10-03
    Sponsor Name:Flevoziekenhuis
    Full Title: Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years.
    Medical condition: Gastro-oesophageal reflux disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017924 Gastroesophageal reflux LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-005169-39 Sponsor Protocol Number: D9914C00002 Start Date*: 2005-08-11
    Sponsor Name:AstraZeneca AB
    Full Title: A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d.
    Medical condition: Symptoms from the upper gastrointestinal tract
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-001157-97 Sponsor Protocol Number: D9614C00099 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of Esomeprazole Magnesium in a Pediatric Population of 1 to 11 Year olds with Gastroesophageal Reflux Disease (GERD...
    Medical condition: The target subject population was male and female children, aged 1 to 11 years inclusive, who suffered from GERD or symptoms of GERD and were candidates for acid suppression therapy.
    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: 2014-001642-16 Sponsor Protocol Number: TAK-390MR_108 Start Date*: 2015-04-24
    Sponsor Name:Takeda Development Centre Europe Ltd.
    Full Title: A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 ...
    Medical condition: Acid-Related Disorders in Infants aged 1 to 11 months
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10066874 Gastroesophageal reflux disease LLT
    17.1 100000004856 10000479 Acid reflux (oesophageal) LLT
    17.1 100000004856 10019326 Heartburn LLT
    17.1 100000004856 10063657 Erosive esophagitis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Temporarily Halted) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-002305-40 Sponsor Protocol Number: STW 5 /212-D-08-II-V Start Date*: 2008-12-09
    Sponsor Name:Steigerwald Arzneimittelwerk GmbH
    Full Title: A double-blind, randomised, placebo-controlled study on the Efficacy of Iberogast® (STW 5) in patients with functional dyspepsia and concomitant reflux symptoms measured with impedance and wireless...
    Medical condition: Patients with typical symptoms of functional dyspepsia (intermittent pain or burning localized to the epigastrum of at least moderate severity at least once per week with a total duration of at lea...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002288-24 Sponsor Protocol Number: Ci-FCP001 Start Date*: 2021-08-10
    Sponsor Name:Amsterdam UMC
    Full Title: Effect of citalopram on chest pain in patients with functional chest pain
    Medical condition: Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-004543-57 Sponsor Protocol Number: D9618C00001 Start Date*: 2006-03-29
    Sponsor Name:AstraZeneca AB
    Full Title: A 6-month randomized, double-blind, parallel-group, multicentre, placebo-controlled Phase II study to compare anti-asthmatic effect and safety of esomeprazole (Nexium) 40 mg twice daily or 40 mg on...
    Medical condition: Moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) HU (Completed) IT (Completed) SK (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2004-003836-77 Sponsor Protocol Number: OCTO-003 Start Date*: 2008-12-09
    Sponsor Name:University of Oxford
    Full Title: AspECT - A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia & oesophagitis.
    Medical condition: Barrett's Metaplasia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-006056-37 Sponsor Protocol Number: 1160.143 Start Date*: 2013-09-05
    Sponsor Name:Hamilton Health Sciences Corporation
    Full Title: A large, international, randomized, placebo-controlled trial to assess the impact of dabigatran (a direct thrombin inhibitor) and omeprazole (a proton-pump inhibitor) in patients suffering myocardi...
    Medical condition: MINS (myocardial injury after noncardiac surgery)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10066592 Post procedural myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) IT (Completed) PT (Completed) ES (Completed) GB (Completed) AT (Completed) DE (Prematurely Ended) CZ (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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