A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.
详细描述
This Phase III, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study aims to observe the efficacy and safety of ORADUR®-Methylphenidate in children and adolescents with ADHD age 6 to 18 years old.
The study is comprised of four main phases: a screening period lasting about 14 days, an open-label titration period lasting 2 to 4 weeks, a double-blind and placebo controlled two-way cross-over study period of 4 weeks (2 weeks for Period 1 and 2 weeks for Period 2), then a follow-up phase of 2 weeks. Screening baseline is defined as Day 0 (Visit 2).
At the last day of the titration period (Day 14 for 22 mg, Day 21 for 33 mg group, and Day 28 for 44 mg group), subjects will be randomly assigned to receive ORADUR®-Methylphenidate at their optimal dose or placebo at a 1:1 ratio according to the randomization scheme during each study period (Period 1 and Period 2) at treatment phase; no washout period will be included between two treatment periods.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo First, then ORADUR®
Placebo once daily for 2 weeks in Period 1 and ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in period 2. (No washout period between two treatment periods)
干预措施: Placebo First, then ORADUR® (Drug)
ORADUR® First, then Placebo
ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in Period 1 and Placebo once daily for 2 weeks in period 2. (No washout period between two treatment periods)
干预措施: ORADUR® First, then Placebo (Drug)
结局指标
主要结局
SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo
时间窗: 2 weeks
To determine the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo
次要结局
- Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo(2 to 4 weeks)
- Clinical Global Impression-ADHD-Severity (CGI-S) score in ORADUR®-Methylphenidate vs. placebo(2 weeks)
- SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period)(2 weeks)
- SNAP-IV parent form score in ORADUR®-Methylphenidate vs. placebo(2 weeks)
- Remission rate in ORADUR®-Methylphenidate vs. placebo(2 weeks)
- Conners' Teacher's Rating Scale score in ORADUR®-Methylphenidate vs. placebo(2 weeks)
- Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate vs. placebo(2 to 4 weeks)
- Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo(2 weeks)