drugset / Trial / NCT01269463

Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

NCT01269463

Phase 3 Completed 26 enrolled Rhodes Pharmaceuticals, L.P.
RandomizedCrossoverQuadruple-blindTreatment

Summary

The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.

Timeline

Start
2011-01-19
Primary completion
2011-06-18
Completion
2013-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 15 mg
Subject Methylphenidate Small molecule 20 mg
Subject Methylphenidate Small molecule 30 mg
Subject Methylphenidate Small molecule 40 mg