114
Participants
Start Date
June 30, 2015
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
Placebo First, then ORADUR®
ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).
ORADUR® First, then Placebo
ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).
National Taiwan University Hospital, Taipei
Tri-Service General Hospital, Taipei
Chang Gung Medical Foundation- Chiayi Branch, Chiayi City
Chang Gung Medical Foundation- Linkuo Branch, Taoyuan District
Collaborators (1)
Durect
INDUSTRY
Orient Pharma Co., Ltd.
INDUSTRY