drugset / Trial / NCT02450890
Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.
Timeline
- Start
- 2015-06
- Primary completion
- 2017-02
- Completion
- 2017-02
Publications
- Shang CY, Chou TL, Hsieh CY, Gau SS. A Counting Stroop Functional Magnetic Resonance Imaging Study on the Effects of ORADUR-Methylphenidate in Drug-Naive Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2022 Nov;32(9):467-475. doi: 10.1089/cap.2022.0024. Epub 2022 Oct 14.
- Huang YS, Yeh CB, Chen CH, Shang CY, Gau SS. A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Clinical Trial of ORADUR-Methylphenidate for Treating Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):164-178. doi: 10.1089/cap.2020.0104. Epub 2020 Dec 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylphenidate | Small molecule | 22 mg | Oral |
| Comparator | Methylphenidate | Small molecule | 33 mg | Oral |
| Comparator | Methylphenidate | Small molecule | 44 mg | Oral |