Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43871   clinical trials with a EudraCT protocol, of which   7290   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Taurine and Painful Diabetic Neuropathy

    Summary
    EudraCT number
    		 2005-004196-37
    Trial protocol
    		 GB  
    Global end of trial date
    21 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2020
    First version publication date
    29 Aug 2020
    Other versions
    Summary report(s)
    		 Summary 2005-004196-37

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RG_05-126
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom, B15 2TT
    Public contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    Scientific contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Aug 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study aims to determine whether neuropathic pain in diabetes can be decreased with the use of taurine through subjective pain measures and electrophysiological measurements.
    Protection of trial subjects
    Inclusion criteria: 1. Type 1/type 2 diabetes, as defined by the WHO Classification.2.Duration of diabetes of at least 5 years.3. HbA1c should be <9% with <1% fluctuation of HbA1c levels over the past 6 months.4.Age between 18 and 70 years. 5.Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. 6.Must meet the specified criteria for painful DN and have no risk factors for other causes for neuropathy. 7.Willingness to sign the Centre for Research Ethics Committee (COREC) approved consent form Exclusion criteria:1.Nursing mothers, pregnant women (excluded by a negative pregnancy test).2.History of drug or alcohol dependence in the last 5 years 3.Pre-existing cardiovascular disease. Hypoxemic disease. 4.Severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain 5.Symptoms of neuropathic pain in the upper limbs alone 6.Significant changes in skin conditions in the areas to be tested which could alter sensation. 7.Previous history of neuropathic foot ulceration or Charcot arthropathy 8.Taking medications that could affect symptoms of painful DN except paracetamol (up to 4 g/d) or aspirin (up to 325 mg/d). 9. Experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the principal investigator (PI), require prohibited analgesic therapy within a 12 wk period. 10.Creatinine clearance is less than 70 ml/min or have significant hepatic disease (AST, ALT, γGT >2 times upper limit for normal). 11.History of previous kidney, pancreas or cardiac transplantation.12, Serious or unstable medical or psychological state that may interfere with study participation.13. Taking other drugs/insulin within 3 months of starting study. 14. Morbidly obese.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 88888
    Worldwide total number of subjects
    88888
    EEA total number of subjects
    88888
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    88888

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Pre-assignment
    Screening details
    		 After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Arms
    Arm title
    		 Overall
    Arm description
    		 After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues
    Arm type
    		 n/a

    Investigational medicinal product name
    Taurine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Number of subjects in period 1
    		Overall
    Started
    88888
    Completed
    88888

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Reporting group values
    		 Overall Total
    Number of subjects
    		 88888 88888
    Age categorical
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues
    Units: Subjects
        Not applicable
    		 88888 88888
    Gender categorical
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues
    Units: Subjects
        Not applicable
    		 88888 88888

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues

    Primary: Not applicable

    		 Close Top of page
    End point title
    		 Not applicable [1]
    End point description
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues
    End point type
    Primary
    End point timeframe
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
    End point values
    		 Overall
    Number of subjects analysed
    88888 [2]
    Units: n/a
    88888
    Notes
    [2] - 88888 is referring to not applicable due to the data integrity issues
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 n/a
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Justification - No adverse events have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 04:42:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA