A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 主要终点
- Dermal Reactions
研究概览
简要总结
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.
详细描述
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator. Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations (not to exceed a two week period) will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign informed consent.
- •Male or female 6-12 years old.
- •Negative pregnancy test.
- •Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
- •No co-morbid illness that could affect safety, tolerability or interfere with participation.
- •Blood pressure (BP) within the 95th percentile for age, gender, and height.
- •Willing and able to comply with all the requirements defined in protocol.
排除标准
- •Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder [ODD]).
- •At risk for suicidal or violent behavior towards self or others.
- •History of a suicide attempt.
- •History of a structural cardiac abnormality or other serious cardiac problems.
- •Non-responder to psychostimulant treatment.
- •Is overweight.
- •Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- •Has Conduct Disorder.
- •Known history of alcohol or other substance abuse within the last 6 months.
- •Any abnormal thyroid function.
- •A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
- •Has had treatment with any known liver altering agents within 30 days prior to Screening.
- •Taking any excluded medication.
- •Previous use of DAYTRANA.
- •Taking other medications that have Central Nervous System (CNS) effects.
- •Female subject is pregnant or lactating.
- •Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
- •Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
- •Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
- •A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
研究组 & 干预措施
Methylphenidate Transdermal System
To characterize the dermal reactions seen with the use of DAYTRANA
干预措施: Daytrana (Drug)
结局指标
主要结局
Dermal Reactions
时间窗: 7 weeks
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
次要结局
- Contact Sensitization to Methylphenidate(7 weeks)