2021
DOI: 10.1089/cap.2020.0104
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A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Clinical Trial of ORADUR-Methylphenidate for Treating Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Abstract: Objective: Methylphenidate (MPH) is efficacious in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD), but there are no data about the efficacy and safety of its new formulation (ORADUR ® -MPH extended release, ORADUR-MPH) in patients with ADHD, which is the study objective. Method: This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, two-way crossover clinical trial. One hundred children and adolescen… Show more

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Cited by 10 publications
(7 citation statements)
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“…Study participants: The studies included were performed in seven countries; the United States, Taiwan, Norway, Australia, the Netherlands, Denmark, and France [6,7,11,[14][15][16][17][18][19][20][21][22][23][24]. The total number of participants recorded was 2,098.…”
Section: General Study Characteristicsmentioning
confidence: 99%
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“…Study participants: The studies included were performed in seven countries; the United States, Taiwan, Norway, Australia, the Netherlands, Denmark, and France [6,7,11,[14][15][16][17][18][19][20][21][22][23][24]. The total number of participants recorded was 2,098.…”
Section: General Study Characteristicsmentioning
confidence: 99%
“…One study assessed MPH and CBT in the included articles [18]. Six studies centered on CBT [15][16][17][18]23,24], while nine researchers centered on MPH administration [6,7,11,14,[18][19][20][21][22]. The dosage of MPH was different in each of the nine studies.…”
Section: Type Of Treatment Considered Dosage and Durationmentioning
confidence: 99%
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“…This meta-analysis included 12 articles [8][9][10][11][12][13][14][15][16][17][18][19], including Pharmacotherapy of Methylphenidate (MPA), Atomoxetine (ATX), Guanfacine Extended-Release (Grx), Lisdexamfetamine Dimesylate (LDX), and tipepidine, as well as non-drug therapies such as psychotherapy, parent training, cognitive therapy, and placebo treatment.…”
Section: Study Characteristics and Medicationsmentioning
confidence: 99%
“…Different pharmacokinetic profiles might be associated with variations in the effects of methylphenidate on the brain (Spencer et al 2010 ). Our recent work has demonstrated the effectiveness of a new once-a-day product of methylphenidate, ORADUR ® -methylphenidate, in reducing the clinical symptoms of children with ADHD (Huang et al 2020 ).…”
Section: Introductionmentioning
confidence: 99%