The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original

June 5, 2022 updated by: Mahidol University

Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders

This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 6 to 12 years
  • Diagnosis of ADHD according to DSM-5 of ICD-10
  • Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
  • Patient who has a stable clinical symptoms.
  • Patients or their legal representatives provide informed consent prior to enrollment

Exclusion Criteria:

  • Patients who present of a serious obstructive gastrointestinal disease
  • Patients cannot swallow the whole tablet
  • Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
  • Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
  • Patients or patients' family have a history of poor compliance
  • Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days
  • Patients who receiving PR-MPH except stop taking more than 7 days
  • Patients' parent has a family problem and currently treatment with family therapy or adjust medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: original
This study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.
Drug: prolong-release methylphenidate
This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.
Other Names:
  • Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate
Active Comparator: generic
This study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.
Drug: prolong-release methylphenidate
This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.
Other Names:
  • Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
Time Frame: baseline, 4 and 8 week
SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms
baseline, 4 and 8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Time Frame: baseline, 4 and 8 week
CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients)
baseline, 4 and 8 week
The difference in discontinuation rate between two groups of treatment
Time Frame: 4 and 8 week
Discontinuation rate is a proportion of patients who discontinue medication from any reason
4 and 8 week
The difference in adverse events rate between two groups of treatment
Time Frame: baseline, 4 and 8 week
adverse events rate is a proportion of patients who have the adverse events
baseline, 4 and 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chanatthida Muangkum, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COA.MU-DT/PY-IRB 2021/033.3003
  • STY.COA004/2564 (Other Identifier: Srithanya hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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