EUCTR2013-004688-30-ITActive, not recruitingPhase 1
Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 635
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The patient has alcohol dependence diagnosed according to ICD-10.
- •The patient has had a high DRL in the 4 weeks preceding the Screening Visit.
- •The patient is a man or woman, aged =18 years.
- •The patient provides a stable address and telephone number.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 620
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
- •The patient has one or more contraindications to the prescription of Selincro®:
- •a. hypersensitivity to the active substance or to any of the excipients,
- •b. taking opioid analgesics,
- •c. current or recent opioid addiction,
- •d. acute symptoms of opioid withdrawal,
- •e. recent use of opioids suspected,
- •f. severe hepatic impairment (Child-Pugh classification),
- •g. severe renal impairment (eGFR <30 ml/min per 1.73 m2),
- •h. a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens).
- •The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >60g for men or >40g for women) in the 4 weeks preceding the Screening Visit.
- •The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required.
- •The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary CareEUCTR2013-004688-30-ESH. Lundbeck A/S635
Active, not recruiting
Not Applicable
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary CareAlcohol DependencyMedDRA version: 18.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2013-004688-30-DEH. Lundbeck A/S379
Active, not recruiting
Phase 1
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary CareEUCTR2013-004688-30-GBH. Lundbeck A/S635
Recruiting
Phase 1
Pilot phase II study of Selinexor in combination with Ifosfamide, Etoposide and Dexamethasone (SIDE) in patients with relapsed or refractory Peripheral T-cell LymphomasRelapsed or Refractory Peripheral T-cell LymphomasMedDRA version: 21.0Level: PTClassification code: 10001416Term: Adult T-cell lymphoma/leukaemia recurrent Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001417Term: Adult T-cell lymphoma/leukaemia refractory Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001413Term: Adult T-cell lymphoma/leukaemia Class: 100000004864CTIS2024-513295-18-00Fondazione IRCCS Istituto Nazionale Dei Tumori30
Active, not recruiting
Phase 1
A study of selinexor in combination with imatinib in patients with metastatic and/or unresectable gastrointestinal tumors (GISTs)EUCTR2017-004761-28-ESGrupo Español de Investigación en Sarcomas41