CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Methylphenidate Hydrochloride Extended Release Capsule +1 moredrug
Likely dose
Methylphenidate Hydrochloride Extended Release Capsule 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01269463
NCT01269463Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind Study of the Time Course of Response to Biphentin® Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting

Rhodes Pharmaceuticals, L.P.·interventional·Posted Jan 4, 2011·Updated Dec 13, 2022

In Brief

A Phase 3 clinical trial evaluating Methylphenidate Hydrochloride Extended Release Capsule and Placebo for Attention Deficit Hyperactivity Disorder and ADHD. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder, ADHD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 4, 2011
Enrollment StartJan 19, 2011
Primary CompletionJun 18, 2011
Study CompletionMar 13, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.5 years ago

Interventions

Methylphenidate Hydrochloride Extended Release Capsuledrug

An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily

Placebodrug

Capsule without active drug