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    The EU Clinical Trials Register currently displays   35475   clinical trials with a EudraCT protocol, of which   5824   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).
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    EudraCT Number:2005-004196-37
    Sponsor's Protocol Code Number:PA02-124 1 RO1AT002146-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-04-13
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-004196-37
    A.3Full title of the trial
    Taurine and Painful Diabetic Neuropathy
    A.4.1Sponsor's protocol code numberPA02-124 1 RO1AT002146-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Birmingham, Research & Enterprise Services
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorHeart of England NHS Foundation Trust Birmingham Heartlands Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTaurine
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 107-35-7
    D.3.9.3Other descriptive name2-aminoethanesulfonic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000 to 1010
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typedietary supplement
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic painful peripheral neuropathy
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    It's second aim is to determine if the reduction of pain can improve mood and quality of life in patients with diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for subjects:

    1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification.
    2. Duration of diabetes of at least 5 years.
    3. The HbA1c should be <12% 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 be meet the specified criteria for painful DN (see below) and have no risk factors for other causes for neuropathy
    7. Willingness to sign the Center for Research Ethics Committee (COREC) approved informed consent form

    E.4Principal exclusion criteria
    Exclusion criteria for subjects:

    1. Nursing mothers, pregnant women (excluded by a negative pregnancy test).
    2. Patients with a history of drug or alcohol dependence in the last 5 years
    3. Patients with pre-existing cardiovascular disease. Patients with hypoxemic disease.
    4. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain
    5. Patients with 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. Subjects with a previous history of neuropathic foot ulceration or Charcot arthropathy
    9. Patients currently taking medications that could affect symptoms of painful DN except acetominophen (up to 3g/d) or aspirin (up to 325 mg/d).
    10 Patients experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the PI, require prohibited analgesic therapy within a 12 wk period.
    11. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (AST, ALT, γGT >2 times upper limit for normal). Patients with TSH outside normal limits
    12. Patients with a history of previous kidney, pancreas or cardiac transplantation.
    13. Serious or unstable medical or psychological state that may interfere with study participation.
    14. Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
    15. Morbidly obese patients (BMI greater than 40).
    16. Patients who refuse to sign the informed consent.

    E.5 End points
    E.5.1Primary end point(s)
    The proposed design is a randomized, double-blind clinical trial of taurine versus placebo, with the primary outcomes being pain and cold detection threshold.

    1. Short-Form McGill-Melzack Pain Questionnaire: A SF-MMPQ is used to determine the effects of taurine treatment on qualitative aspects of pain perception. The SF-MMPQ comprises a sensory score, an affective score and a total score for various pain descriptors; a visual analogue scale (VAS) to assess overall pain intensity and a present pain rating intensity index (PPI). The SF-MMPQ contains 15 descriptions of pain, 11 of which represent the sensory dimension of painful experience and 4 of which represent the affective dimension. Each of these pain descriptions is then ranked by the subject on a 4 point scale and totally within subclasses. The overall intensity of the pain is scored using the 6-point PPI and the VAS. This questionnaire, together with the daily pain diaries, the clinical and patient global assessment of change, forms the basis of the assessment of changes in pain in this study.

    2. Mean Sleep Interference Score: Decreased nocturnal pain perception may be associated with improved sleep. This will be assessed using a standardized sleep interference score. Mean sleep interference scores are calculated at baseline (ie the week preceding the randomization visit) and for the final week of the study (between visits B and C). The diary that is utilized for sleep assessment comprises a daily diary with an 11-point Likert-type scale which describes the degree to which the subject’s pain has interfered with sleep during the preceding 24 h. The scale ranges from zero (pain does not interfere with sleep to 10 (pain completely interferes with sleep). The assessment is performed on a daily basis upon awakening. The end-point mean sleep interference score is calculated as the mean score for the last 7 dairy entries while the subject was taking the study drug.

    3. Mean Pain Scores from Screening to Study End: The subjects daily diaries are used to compute the mean pain scores in each treatment group from the screening visit to the study end. The daily diary comprises an 11-point Likert-type scale which ranges from 0 (no pain) to 10 (worst possible pain). The degree of neuropathic pain that has been experienced by the subject is rated by selecting a number from 0 to 10. This diary is completed upon awakening. The end-point mean pain score is calculated as the mean score for the last 7 dairy entries while the subject was taking the study drug.

    4. Clinical and Patient Global Impression of Change: These measures of global impression of change are evaluated by both the physician and the patient at the final visit. The Clinical Global Impression of Change is a clinician-rated instrument which measures the change in the subjects overall status on a 7-point scale which ranges from 1 (very much improved) to 7 (very much worse). In parallel, the subject completes a Patient Global Impression of Change which measures the subjects overall status using a similar 7-point scale.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit of the subject enrolled in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-21
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