A Phase II, randomized, multi-centric, open-label, two arm study to determine the safety profile and establish the efficacy of Xprenor® (buprenorphine oral lyophilisate) in comparison with Subutex® (buprenorphine hydrochloride) in opioid dependent patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- 1. To compare Oxygen desaturation as measured by pulse oximetry
研究概览
简要总结
This study is designed to determine the safety profile and establish the efficacy of Xprenor (buprenorphine oral lyophilisate) in comparison with Subutex (buprenorphine hydrochloride) in opioid dependent patients.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The study consists of an induction period of up to 7 days where patients identify a dose of Xprenor (buprenorphine oral lyophilisate) or Subutex [(buprenorphine hydrochloride), an effective and approved treatment for opioid dependence], followed by a maintenance period of 7 days on the dose identified. At the end of the maintenance period, all patients will be switched to the prevailing standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Clinical condition: Opioid dependent patients, eligible for opioid substitution therapy. 2.Gender: Male or Female.
- •60 years (both inclusive).
- •BMI: 18.0 to 30.0 Kg/m2
- •Capable of providing voluntary informed consent.
- •Female patients who are sexually active will be of non-child bearing potential (i.e., surgically sterilized or postmenopausal), abstain from sexual intercourse, or use a reliable method of contraception (e.g. hormonal contraceptive, condom with spermicide, IUD) for at least 30 days prior to dosing and during the duration of the study.
排除标准
- •1.Current or previous (within previous 2 days) dependence treatment, e.g. buprenorphine or methadone.
- •2.Hypersensitivity to buprenorphine or any other component of the oral lyophilisate.
- •3.Positive urine drug test for cocaine or amphetamines at screening.
- •4.Severe hepatic insufficiency (defined as liver function tests, including alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, greater than three times the upper limit of normal).
- •5.Concomitant use of benzodiazepines, which may potentiate respiratory depression, above recommended therapeutic doses or patients who are not stabilized on benzodiazepine therapy.
- •6.Concomitant use of other central nervous system depressant, such as other opioid derivatives, certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances.
- •7.Concomitant use of monoamine oxidase inhibitors, which may aggravate opioid effects.
- •8.Administration of any approved or investigational long-acting injections of antipsychotic medications.
- •9.Current psychiatric diagnosis of major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the patient’s ability to complete the study.
- •10.Female patients with a positive pregnancy test, lactating mother, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial.
- •11.Participation in a clinical trial of a pharmacological agent within 6 months of screening.
结局指标
主要结局
1. To compare Oxygen desaturation as measured by pulse oximetry
时间窗: Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14
2.To monitor respiration rate
时间窗: Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14
3.To compare the incidence of AEs and SAEs reported in Subutex (buprenorphine hydrochloride) and Xprenor (Buprenorphine oral lyophilisate) arms
时间窗: Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14
次要结局
- 1.To evaluate and compare the reduction in opioid withdrawal symptoms(2.To evaluate and compare the reduction in scores on the Objective and Subjective Opioid Withdrawal Scale)