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Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

NCT ID: NCT02704390

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-08-31

Brief Summary

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The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Detailed Description

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In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will be invited to join this extension study for 24-month follow-up. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose.

Conditions

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Attention Deficit Hyperactivity Disorder

Keywords

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ORADUR®-Methylphenidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORADUR®-Methylphenidate

ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.

Group Type EXPERIMENTAL

ORADUR®-Methylphenidate

Intervention Type DRUG

ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.

Interventions

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ORADUR®-Methylphenidate

ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment
2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study

Exclusion Criteria

1. Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
2. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation
3. Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation.
4. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
5. By the investigators' discretion, subjects cannot understand or follow the instructions given in the study
6. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Durect

INDUSTRY

Sponsor Role collaborator

Orient Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shirley Lin

Role: STUDY_DIRECTOR

Orient pharma

Locations

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Chang Gung Medical Foundation- Chiayi Branch

Chiayi City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation- Linkuo Branch

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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OP-2PN012-301E

Identifier Type: -

Identifier Source: org_study_id