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Trial record 20 of 439 for:    Methylphenidate

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

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ClinicalTrials.gov Identifier: NCT02450890
Recruitment Status : Unknown
Verified December 2016 by Orient Pharma Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Durect
Information provided by (Responsible Party):
Orient Pharma Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Placebo First, then ORADUR® Drug: ORADUR® First, then Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Study Start Date : June 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®
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).

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
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).




Primary Outcome Measures :
  1. SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    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


Secondary Outcome Measures :
  1. SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period) [ Time Frame: 2 weeks ]
    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.

  2. SNAP-IV parent form score in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    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.

  3. Remission rate in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    To determine the remission rate of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

  4. Conners' Teacher's Rating Scale score in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    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.

  5. Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 to 4 weeks ]
    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.

  6. Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 to 4 weeks ]
    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.

  7. Clinical Global Impression-ADHD-Severity (CGI-S) score in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    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.

  8. Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo [ Time Frame: 2 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450890


Locations
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Taiwan
Chang Gung Medical Foundation- Chiayi Branch
Chiayi, Taiwan
Tri-Service General Hospital
Taipei City, Taiwan, 114
National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Medical Foundation- Linkuo Branch
Taoyuan, Taiwan
Sponsors and Collaborators
Orient Pharma Co., Ltd.
Durect
Investigators
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Study Director: Chi-Tai Chang, PhD Orient Pharma Co., Ltd.

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Responsible Party: Orient Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02450890     History of Changes
Other Study ID Numbers: OP-2PN012-301
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Keywords provided by Orient Pharma Co., Ltd.:
ORADUR®-Methylphenidate
Additional relevant MeSH terms:
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Methylphenidate
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents