A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 主要终点
- Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.
详细描述
To date, all prior trials involving intramuscular injection of paliperidone palmitate were conducted with buttock administration. This is a randomized, multicenter, crossover design study in evaluating safety and tolerability of paliperidone palmitate in two different injection sites. The study hypothesis is that there will be no difference in safety and tolerability between buttock injection compared to shoulder injection at any of the three different doses of paliperidone palmitate. The patients will receive intramuscular injections of paliperidone palmitate in either their buttocks or in their shoulders
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have signed an informed consent
- •The patient must meet the diagnostic criteria for schizophrenia
- •Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening
- •The patient must be able to perform study requirements (e.g. answer questionnaire)
排除标准
- •Primary, active diagnosis other than schizophrenia
- •Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days
- •Change in their antipsychotic medication in the past 45 days
- •Diagnosis of active substance dependence within 3 months
- •History of treatment resistance
- •History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)
结局指标
主要结局
Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
次要结局
- Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial