CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 194 enrolled
Drug / intervention
Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) +1 moredrug
Likely dose
Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) 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/NCT01933880
NCT01933880Phase 4Completed
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An Open, Self-Controlled, Prospective Study of Concerta on Cognitive Functions, Efficacy and Tolerance in the Pediatric Patients With Attention Deficit Hyperactivity Disorder (ADHD)

Xian-Janssen Pharmaceutical Ltd.·interventional·Posted Sep 2, 2013·Updated Sep 17, 2014

In Brief

A Phase 4 clinical trial evaluating Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) and No intervention for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 194 participants across 6 sites.

Detailed Summary

The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2013
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.8 years ago

Interventions

Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)drug

Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance.

No interventionother

Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.