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    Summary
    EudraCT Number:2007-004663-22
    Sponsor's Protocol Code Number:NRL972-05/2007 (ETOH)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-004663-22
    A.3Full title of the trial
    A multi-centre, open short term follow-up Phase II study to evaluate the clearance of NRL972 in patients undergoing alcohol withdrawal commencing in a controlled clinical setting.
    A.3.2Name or abbreviated title of the trial where available
    NRL972 in patients attempting alcohol cessation
    A.4.1Sponsor's protocol code numberNRL972-05/2007 (ETOH)
    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 SponsorNorgine Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameCholyl-Lysyl-Fluorescein
    D.3.2Product code NRL972
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorescein lisicol
    D.3.9.1CAS number 463932-51-6
    D.3.9.2Current sponsor codeNRL972
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    Alcoholic liver disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001627
    E.1.2Term Alcoholic liver disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the present study is to investigate a change in clearance of NRL 972 after 4 weeks in comparison to baseline day 1 in patients undergoing alcohol withdrawal therapy.
    E.2.2Secondary objectives of the trial
    To investigate the relationship between the pharmacokinetics of NRL972 & disease-associated clinical matrix criteria that express severity of hepatic dysfunction.

    One of the additional secondary objective of the present study is to investigate a change in clearance of NRL 972 at the end of the alcohol withdrawal therapy (maximum: 6 weeks) in comparison to baseline day 1.

    Safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient has given his/her written informed consent to the study participation, prior to study specific procedures
    • Ethnicity: any
    • Male and female (non-child-bearing potential = post-menopausal or medically adequate contraception)
    • Age between 18 to 75 years
    • Alcohol dependence according to DSM-IV-TR
    • A minimum of 2 years of alcohol dependence
    • Last alcohol consumption within the last 28 days prior inclusion in the study assured by successful detoxification (see below) and undergoing rehabilitation for alcohol withdrawal
    • No severe signs of withdrawal and a minimum of 7 days of abstinence
    • Motivation to stop alcohol consumption in a controlled clinical setting for at least 4 weeks
    • Laboratory signs of ethanol induced hepatic dysfunction, i.e. at least one LFT > 2x ULN
    • Medically fit to undergo the protocol-defined procedures without undue risk and discomfort
    E.4Principal exclusion criteria
    • Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial NRL972 test)
    • Participant in any other trial during the last 90 days
    • Donation of blood during the last 90 days or a history of blood loss exceeding 300 mL within the last 90 days
    • Any donation of germ cells, blood, organs, or bone marrow before or during the course of the study
    • History of any clinically relevant allergy (including hypersensitivity to the trial medications)
    • Presence of clinically relevant acute or chronic infection (other than chronic viral hepatitis, if applicable)
    • Use of confounding concomitant medication (see Section 7.5.7)
    • Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic dysfunction) such as: malignancy and clinically relevant systemic diseases
    • Considered unsuitable for participation by the judgement of the investigator
    • Suspicion or evidence that the patient is not able to make a free consent or to understand the information in this regard
    • Previous liver transplantation or intended liver transplantation within 6 months after enrolment
    • Patients who are employees at the investigational site, relatives or spouses of the investigator
    • Current clinical relevant drug dependency according to the investigator’s clinical judgement
    • Any present or past regular opiate use
    Special restrictions for female patients:
    • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the definition of post-menopausal (either females with an age of >55 years plus 12 months of natural (spontaneous) amenorrhea or females with an age below 55 years plus 12 months of spontaneous amenorrhea with serum FSH levels > 40 MIE/mL and oestrogen deficiency with a serum level of <30pg/mL or a negative oestrogen test) or 6 weeks
    post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
    E.5 End points
    E.5.1Primary end point(s)
    The pre-post difference of the clearance of NRL 972. The baseline value at day 1 will be subtracted from the value after 4 weeks to assess any changes in liver function.
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned25
    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 No
    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
    last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 180
    F.4.2.2In the whole clinical trial 180
    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 Decision2008-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-21
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