E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001627 |
E.1.2 | Term | Alcoholic liver disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
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last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |