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    Summary
    EudraCT Number:2006-003571-12
    Sponsor's Protocol Code Number:GLU0409
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-003571-12
    A.3Full title of the trial
    Breath Methionine and Other Indices of Oxidant Stress in the Critical Care Setting. The effect of two doses of Dipeptiven given independently of parenteral nutrition.
    A.3.2Name or abbreviated title of the trial where available
    Breath Methionine and Dipeptiven in Critical Illness
    A.4.1Sponsor's protocol code numberGLU0409
    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 SponsorBarts and the London NHS Trust
    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.4.2Country
    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 Yes
    D.2.1.1.1Trade name Dipeptiven
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Limited, Melbury Park, Birchwood, Warrington, Cheshire, WA3 6FF
    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.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN(2) -L-alanyl-L-glutamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-alanine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number82
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-glutamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number134.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    60 consecutive critically ill patients will be recruited with illnesses such as severe infection, trauma and post-surgery.
    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
    Critically ill patients often become septic due to severe infection. The function of liver can become strained in this situation, however it is difficult for clinicians to determine how strained the liver actually is. Methionine is an essential amino acid that humans obtain from beef, fish, beet and dairy products. The methionine is metabolised almost exclusively in the liver. Therefore by attaching a radiolabelled carbon 13 atom to the methionine we can measure how much of the methionine has been metabolised and therefore how well the liver is functioning. The primary objective of this study is to show that in critically ill patients the amount of methionine metabolised by the liver is reduced on day 5 in the intensive care unit compared to admission (day 0).
    E.2.2Secondary objectives of the trial
    1)In critically ill patients Glutamine is another amino acid which has been shown to be beneficial in critically ill patients. We would like to show that by administering glutamine (in the form of dipeptiven) we can protect the liver from becoming strained in critical illness.
    (2) Measure glutamine levels in the 3 groups of patients.
    (3) Measure glutathione peroxidase in the 3 groups. Glutathione peroxidase is a substance in the body which acts against toxic waste products and converts them into water. Glutamine in the body is converted into glutathione and glutathione is essential for glutathione peroxidase to perform its function.
    (4) We will also measure the effect of giving glutamine has on reducing infections, nutritional status of the patient, length of hospital stay and quality of life of the patient on discharge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18-80 who are likely to remain on the intensive care unit for at least 72 hours as deemed by the consultant in charge of the intensive care unit at the time of admission of the patient.
    E.4Principal exclusion criteria
    Pregnancy
    Portasystemic Encephalopathy
    Prolonged International Normalised Ration (INR) >1.4
    Severe Head or Brain Injury
    Patients not requiring a nagogastric or orogastric tube as part of routine care on the intensive care unit
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be change in breath methionine between baseline and day 5 (or last day on ICU if earlier) by group. 12 patients per group will give 80% power to detect differences in the primary outcome of at least one standard deviation assuming a two sided type 1 error of 5%. However, after adjusting for a drop out rate of 25% and the number of comparisons with a two sided type 1 error of 2.5% a total of 20 patients per group will be needed. Parametric tests (paired and unpaired t-tests, ANOVA, Mann-Whitney, Kruskal-Wallis) will be used as appropriate. Results will be expressed as (1) the percentage of administered 13C recovered per hour (%13C dose/h) according to the formula by Schoeller et al(64); (2) maximal percentage 13C dose/h value observed at any time (`peak’ value); and (3) cumulative percentage of the dose of the administered 13C recovered during a 2 hour period (%13C cumulative dose, CPDR 120 or 180) derived by the trapezoidal rule from %13C dose/h. All these values are calculated by assuming the basal CO2 production at a constant rate of 300 mmol/h/m2 of body surface area. The intensive care unit of The Royal London admits approximately 700 patients per year, the majority of whom are ventilated for airway management. It will be possible to recruit 60 patients in a 2 month period. Secondary end points will include

    1. Malondialdehyde as a measure of oxidative status day 0,2, and 5
    2. Plasma glutamine concentration day 0, 2 and 5
    3. Plasma glutathione peroxidase day0, 2 and 5
    4. Correlation of breath methionine with antioxidant measures
    5. Multiple regression of breath methionine on antioxidant measures, liver function tests glutamine dose, age sex, diagnosis
    6. Clinical outcome, sepsis rates, SOFA change, death (ICU, hospital).
    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 Yes
    E.6.4Safety Yes
    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.7.1.3.1Other 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 trial will end when 60 patients are recruited
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patients being recruited to this trial are critically ill patients. The vast majority will need ventilator machines to help them breathe and they will be unable to give them consent themselves. The next of kin will be asked to give assent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    Patients will be treated exactly the same as any other patient on the critical care unit after the trial has ended accoring to the units protocols.
    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 Decision2006-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-02
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