CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 142 enrolled
Drug / intervention
Osmotic Release Oral System (OROS) Methylphenidate Hydrochloridedrug
Likely dose
Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride 18 milligramfrom 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/NCT01012622
NCT01012622Phase 4Completed
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An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children With ADHD (FOSCO)

Janssen Korea, Ltd., Korea·interventional·Posted Nov 13, 2009·Updated Mar 14, 2014

In Brief

A Phase 4 clinical trial evaluating Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 142 participants.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2009
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.6 years ago

Interventions

Osmotic Release Oral System (OROS) Methylphenidate Hydrochloridedrug

OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.