A Randomised, Double-Blind, Double-Dummy, Active-Drug-Controlled, Parallel-Group, Multicentre Acceptability and Safety Study of the Transfer from Subutex®/Suboxone® to RBP-6300 in Opioid-Dependent Subjects

Reckitt Benckiser Pharmaceuticals0 个研究点目标入组 140 人开始时间: 2011年9月14日最近更新: 2013年1月28日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 140

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Subjects must be male or non-pregnant, non-lactating females.
•2. Subjects must be at least 18 years of age.
•3. Subjects must provide written informed consent and must be willing that their general practitioners be notified of their participation in the study.
•4. Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 3 months after the last dose of study drug. Women of childbearing potential are defined as all women who have not had a complete surgical hysterectomy or who cannot be documented as being at least 1 year postmenopausal. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or double-barrier contraception. Use of two medically acceptable methods of birth control, one of which being a barrier method, may be needed according to local requirements or regulations (this will be reflected in the local informed consent form). Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug.
•5. Subjects must be able to communicate well with the investigator, understand and comply with the requirements of the study, and understand the written informed consent.
•6. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for opioid dependence at screening.
•7. Subjects must have been receiving maintenance treatment with Suboxone® or Subutex® at stable daily doses of 8, 16, or 24 mg/day for =30 days prior to screening and must be
•considered by the investigator to be suitable for continuing such treatment.
•8. Female subjects of childbearing potential must have a negative urine ß-hCG or plasma (dependent on local regulations) test prior to enrolment into the study.
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

排除标准

•1. Subjects who are unwilling or unable to comply with the requirements of the protocol or who are in a situation or have a condition that, in the opinion of the investigator, may interfere with participation in the study.
•2. Subjects who, within 2 months prior to signing the informed consent document, participated in any other clinical study in which medications were delivered or who plan to participate in any other clinical study prior to the Follow-up Visit of the present trial.
•3. Subjects who are receiving treatment for opioid dependence by court order.
•4. Subjects with known allergy or sensitivity to buprenorphine or naloxone or to any of the excipients of Subutex®/Suboxone® or RBP-6300.
•5. Subjects who are staff personnel or are affiliated with or a family member of staff personnel directly involved in the study.
•6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (for example, those who are actively suicidal as per C-SSRS or have untreated schizophrenia).
•7. Subjects with significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification. Current polysubstance abuse or dependence is not a reason for exclusion.
•8. Subjects with a current diagnosis of chronic pain requiring opioid treatment.
•9. Subjects with an ECG result that shows a repeated demonstration of a QTc interval >450ms or a history of risk factors of Torsades de Pointes (eg heart failure, hypokalemia,
•family history of Long QT Syndrome)
•10. Subjects with aspartate aminotransferase (AST) levels =3 × upper limit of normal (ULN), alanine aminotransferase (ALT) levels =3 × ULN, or total bilirubin levels =1.5 × ULN.
•11. Subjects with uncontrolled medical or psychiatric illness.
•12. Subjects currently using opioid treatment (except buprenorphine), other opioid derivatives (e.g., methadone and analgesics), clonidine and related substances and clinically relevant CYP3A4 inhibitors or inducers.
•13. Subjects with an opioid-positive (other than for buprenorphine) UDS result, a COWS score > 12, or a drug-craving VAS > 20 mm at screening or during the Open-Label Runin Phase.
•14. Subjects positive for human immunodeficiency virus (HIV), or showing evidence of acute hepatitis B or C infection—acute infection is defined as subjects positive for hepatitis B surface antigen (HBsAg) and immunoglobulin M antibodies to hepatitis B core antigen (anti-HBc IgM),
•and those with clinical evidence of either acute hepatitis B infection or hepatitis C infection. Subjects with chronic active hepatitis should also be excluded Subjects with asymptomatic hepatitis B or C infection and those asymptomatic currently being treated may be enrolled.
•15. Subjects for whom treatment with Subutex®/Suboxone® is a contraindication as per the Summary of Product Characteristics (SmPC), such as subjects with severe respiratory insufficiency or severe hepatic insufficiency.

研究者

发起方

Reckitt Benckiser Pharmaceuticals

相似试验

进行中（未招募）

不适用

ot applicableMaintenance/substitution agent for the treatment of opioid dependenceMedDRA version: 14.1Level: LLTClassification code 10012346Term: Dependence on opiatesSystem Organ Class: 10037175 - Psychiatric disorders

EUCTR2011-003047-22-CZReckitt Benckiser Pharmaceuticals140

进行中（未招募）

不适用

EUCTR2011-003047-22-DEReckitt Benckiser Pharmaceuticals140

进行中（未招募）

不适用

EUCTR2011-003047-22-SEReckitt Benckiser Pharmaceuticals140

已完成

1 期

A study to determine the safety, maximum tolerable dose and ability to provoke an immune response of the Codavax Influenza Vaccine in healthy volunteers. Part 2Influenza

ACTRN12618000557235Clinical Network Services Pty Ltd50

已完成

1 期

A study to determine the safety, maximum tolerable dose and ability to provoke an immune response of the Codavax Influenza Vaccine in healthy volunteers.influenza

ACTRN12617000254392Clinical Network Services Pty Ltd75