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| ID | Type | Description | Link |
|---|---|---|---|
| STY.COA004/2564 | Other Identifier | Srithanya hospital |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| original | Experimental | 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. |
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| generic | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prolong-release methylphenidate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in Clinical Global Impression-Severity (CGI-S) scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chanatthida Muangkum | Contact | 6654419935 | chanatt.mua@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chanatthida Muangkum | Mahidol University | Principal Investigator |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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 | adverse events rate is a proportion of patients who have the adverse events | baseline, 4 and 8 week |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |