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CompletedNCT02450890Updated Dec 6, 2021

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

A Phase 3 interventional study of Placebo First, then ORADUR® and ORADUR® First, then Placebo in Attention Deficit Hyperactivity Disorder, sponsored by Orient Pharma Co., Ltd.. Completed at 4 sites in Taiwan. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by Orient Pharma Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

This Phase III, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study aims to observe the efficacy and safety of ORADUR®-Methylphenidate in children and adolescents with ADHD age 6 to 18 years old.

The study is comprised of four main phases: a screening period lasting about 14 days, an open-label titration period lasting 2 to 4 weeks, a double-blind and placebo controlled two-way cross-over study period of 4 weeks (2 weeks for Period 1 and 2 weeks for Period 2), then a follow-up phase of 2 weeks. Screening baseline is defined as Day 0 (Visit 2).

At the last day of the titration period (Day 14 for 22 mg, Day 21 for 33 mg group, and Day 28 for 44 mg group), subjects will be randomly assigned to receive ORADUR®-Methylphenidate at their optimal dose or placebo at a 1:1 ratio according to the randomization scheme during each study period (Period 1 and Period 2) at treatment phase; no washout period will be included between two treatment periods.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ORADUR®-Methylphenidate
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 114 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Orient Pharma Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main inclusion criteria:

  1. Female or male subjects with age between 6 and 18 years old.
  2. Subjects with documented diagnosis of one of the three presentations of Attention Deficit Hyperactivity Disorder (ADHD) within one year by investigator assessment using Diagnostic \& Statistical Manual for Mental Disorders-Fifth Edition (DSM-5).
  3. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study.

Main exclusion criteria:

  1. Subjects have received ADHD treatment for over 1 year or those who have received other ADHD treatment within 30 days prior to the study treatment initiation.
  2. By investigator's evaluation, subjects are very anxious, tense or agitated.
  3. Subjects known to be allergic to any ORADUR®-methylphenidate ingredients.
  4. Subjects with an estimated intelligence quotient (IQ) \< 80.
  5. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI)) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation.
  6. Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation.
  7. Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder.
  8. Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome.
  9. Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract.
  10. Subjects/caregivers are (in the case of subjects whose parents/caregivers were to fill out the study questionnaires) with drug or alcohol abuse/dependence within the prior 6 months.
  11. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety.
  12. In the investigators' opinion, subjects cannot understand or follow the instructions given in the study.
  13. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
114 participants (actual)

Study arms

  • Placebo comparator
    Placebo First, then ORADUR®

    Placebo once daily for 2 weeks in Period 1 and ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in period 2. (No washout period between two treatment periods)

    Drug: Placebo First, then ORADUR®

  • Experimental
    ORADUR® First, then Placebo

    ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in Period 1 and Placebo once daily for 2 weeks in period 2. (No washout period between two treatment periods)

    Drug: ORADUR® First, then Placebo

Interventions

  • DrugPlacebo First, then ORADUR®

    ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).

    Also known as: Placebo

  • DrugORADUR® First, then Placebo

    ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo

    To determine the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo

    Time frame: 2 weeks

Secondary outcomes

  1. SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period)

    To examine changes of the Swanson, Nolan, and Pelham-IV (SNAP-IV) parent form scores in children and adolescents with ADHD administered ORADUR®-Methylphenidate at different dose schedules in the titration period.

    Time frame: 2 weeks

  2. SNAP-IV parent form score in ORADUR®-Methylphenidate vs. placebo

    To determine the Swanson, Nolan, and Pelham-IV (SNAP-IV) parent form score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 weeks

  3. Remission rate in ORADUR®-Methylphenidate vs. placebo

    To determine the remission rate of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 weeks

  4. Conners' Teacher's Rating Scale score in ORADUR®-Methylphenidate vs. placebo

    To determine the Conners' Teacher's Rating Scale score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 weeks

  5. Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate vs. placebo

    To determine the Conners' Continuous Performance Test (CPT-II) performance of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 to 4 weeks

  6. Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo

    To determine the Diagnostic \& Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 to 4 weeks

  7. Clinical Global Impression-ADHD-Severity (CGI-S) score in ORADUR®-Methylphenidate vs. placebo

    To determine the Clinical Global Impression-ADHD-Severity (CGI-S) score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 weeks

  8. Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo

    To determine the Clinical Global Impression-ADHD-Improvement (CGI-I) score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

    Time frame: 2 weeks

07

Study locations

4 sites
  • Chang Gung Medical Foundation- Chiayi Branch
    Chiayi City, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Tri-Service General Hospital
    Taipei, 114, Taiwan
  • Chang Gung Medical Foundation- Linkuo Branch
    Taoyuan, Taiwan
08

References and documents

Publications

  • Shang CY, Chou TL, Hsieh CY, Gau SS. A Counting Stroop Functional Magnetic Resonance Imaging Study on the Effects of ORADUR-Methylphenidate in Drug-Naive Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2022 Nov;32(9):467-475. doi: 10.1089/cap.2022.0024. Epub 2022 Oct 14. PubMed 36251766 ↗
  • Huang YS, Yeh CB, Chen CH, Shang CY, Gau SS. A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Clinical Trial of ORADUR-Methylphenidate for Treating Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):164-178. doi: 10.1089/cap.2020.0104. Epub 2020 Dec 31. PubMed 33395356 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Feb 2017 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2015
First posted
May 21, 2015
Start
Jun 2015
Primary completionActual
Feb 2017
CompletionActual
Feb 2017
Last update
Dec 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02450890
Lead sponsor
Orient Pharma Co., Ltd.
Collaborators
Durect
Responsible party
Sponsor
First posted
May 21, 2015
Start date
Jun 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Dec 6, 2021

Study contacts

Chi-Tai Chang, PhD
study director · Orient Pharma Co., Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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