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Clinical trials for rabeprazole sodium

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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    9 result(s) found for: rabeprazole sodium. Displaying page 1 of 1.
    EudraCT Number: 2016-001896-63 Sponsor Protocol Number: E3810-A001-015 Start Date*: 2016-06-27
    Sponsor Name:Eisai Medical Research Inc.
    Full Title: An Ascending Bioavailability of a New Oral Suspension of E3810
    Medical condition: Bioavailability/Bioequivalence
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001879-73 Sponsor Protocol Number: E3810-A001-202 Start Date*: 2016-06-27
    Sponsor Name:Eisai Medical Research Inc.
    Full Title: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
    Medical condition: Gastroesophageal Reflux Disease
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001878-15 Sponsor Protocol Number: E3810-A001-119 Start Date*: 2016-06-27
    Sponsor Name:Eisai Medical Research Inc.
    Full Title: Single and Multiple Dose Pharmacokinetics and Safety Study of Rabeprazole Sodium in 12 to 16 Year Old Subjects
    Medical condition: Gastroesophageal Reflux Disease (GERD)
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-004847-12 Sponsor Protocol Number: RABGRD3004 Start Date*: 2009-11-04
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed-Release Rabeprazole in 1- to 11-Month-Old Pediatric Subj...
    Medical condition: Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 month old subjects
    Disease: Version SOC Term Classification Code Term Level
    12.0 10018203 GERD LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) NL (Completed) IT (Completed) BG (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-000452-27 Sponsor Protocol Number: RABGRD1003 Start Date*: 2008-05-16
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months old, Inclusive
    Medical condition: Pediatric subjects with GERD
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018203 GERD LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-000451-97 Sponsor Protocol Number: RABGRD1002 Start Date*: 2008-04-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Years old, inclusive
    Medical condition: Pediatric subjects with GERD (endoscopically proven) and have had endoscopic examination as part of their diagnostic evaluation; 1 to 11 Years Old, inclusive
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018203 GERD LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015885-75 Sponsor Protocol Number: RABGRD1005 Start Date*: 2010-07-02
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks wit...
    Medical condition: Gastroesophageal reflux disease (GERD) in neonates and pre-term infants, with a corrected age of less than 44 weeks at the time of the first dose.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10017947 - Gastrointestinal disorders 10018203 GERD LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004837-54 Sponsor Protocol Number: RABGRD3003 Start Date*: 2009-03-05
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formul...
    Medical condition: Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018203 GERD LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) FR (Completed) NL (Ongoing) IT (Completed) BG (Not Authorised)
    Trial results: View results
    EudraCT Number: 2013-000759-41 Sponsor Protocol Number: 34 Start Date*: 2014-03-27
    Sponsor Name:Fondazione Toscana Gabriele Monasterio
    Full Title: A prospective, open-label, single center, cross-over, controlled, randomized, phase III study to test superiority of the oral solution of synthetic thyroxine compared to tablet preparation for tr...
    Medical condition: Hypothyroidism
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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