Other Clinical Trial - An Efficacy & Safety Study of Osmotic Release Oral

Status Completed

Clinical Trial 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).

Clinical Trial Description

This is an open-label (all people involved know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), prospective study (study following participants forward in time) to evaluate the efficacy and safety of OROS methylphenidate in participants with ADHD (behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity). The study duration will be of 12 weeks per participant, which is divided into 2 parts Screening (within 14 days before study commences on Day -1) and treatment (8 weeks and will include titration period [from the initiation of the study treatment to determination of the individual's maintenance dose] and maintenance period [at least 4 weeks after determination of maintenance dose]). Participants will receive initial dose depending on their body weight. 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. Efficacy will be evaluated by Korean Version, ADHD Rating Scale (K-ARS) total score and Clinical Global Impression)-Severity / Impression rating scale CGI-S/I. Participants safety will be monitored throughout the trial. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Attention Deficit Disorder With Hyperactivity
Hyperkinesis

Clinical Trial Details

NCT number	NCT01012622
Study type	Interventional
Source	Janssen Korea, Ltd., Korea
Contact
Status	Completed
Phase	Phase 4
Start date	September 2008
Completion date	August 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00202605` - Safety and Efficacy of SPD465 in Adults With ADHD	Phase 2
Not yet recruiting	`NCT02677519` - A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD	Phase 4
Completed	`NCT02730572` - Concerta (Methylphenidate) -To-Generic Switch Study	N/A
Completed	`NCT01681082` - Psychological Effects of Tai Chi Training	N/A
Active, not recruiting	`NCT01330693` - Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy	Phase 3
Completed	`NCT00830700` - Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study	N/A
Completed	`NCT00626236` - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems	Phase 2
Completed	`NCT00598182` - Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study	N/A
Completed	`NCT00381407` - Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder	N/A
Completed	`NCT00178503` - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children	Phase 2/Phase 3
Completed	`NCT00247572` - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Phase 2
Completed	`NCT00557011` - NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD	Phase 2
Completed	`NCT00118911` - Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder	N/A
Completed	`NCT00218322` - Effectiveness of ATMX in Treating Adolescents With ADHD and SUD	Phase 4
Completed	`NCT00071656` - Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I	N/A
Active, not recruiting	`NCT00057668` - Preventing Behavior Problems in Children With ADHD	Phase 2
Completed	`NCT00050622` - Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT00050050` - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder	Phase 1
Completed	`NCT00031395` - Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children	Phase 3
Completed	`NCT00000388` - Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA)	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms