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

M

Mahidol University

Status

Not yet enrolling

Conditions

Adhd

Treatments

Drug: prolong-release methylphenidate

Study type

Interventional

Funder types

Other

Identifiers

NCT05410626
COA.MU-DT/PY-IRB 2021/033.3003
STY.COA004/2564 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

78 participants in 2 patient groups

original
Experimental group
Description:
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.
Treatment:
Drug: prolong-release methylphenidate
generic
Active Comparator group
Description:
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.
Treatment:
Drug: prolong-release methylphenidate

Trial contacts and locations

0

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Central trial contact

Chanatthida Muangkum

Data sourced from clinicaltrials.gov

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