Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RRA 14797 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA] methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG] methylphenidate} that was begun on the index date), differs between participants who switch from branded Concerta to the EG formulations versus participants who switch from branded Concerta to the AG formulation.
This is a retrospective cohort study based on a health claims database, the Truven Commercial Claims and Encounters (CCAE) database. Participants will enter the cohort when, after using Concerta continuously for at least 60 days after October 3, 2012, they receive a dispensing of the AG or EG formulation within 15 days of the end of the days of Concerta supplied. The date of that dispensing of the AG or EG formulation is the participants index date. This study will track various events, example, back-switches, and methylphenidate dose changes over time (the 60 days before the switch from Concerta to an AG or EG generic compared to the 60 days after that switch).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concerta to authorized generic (AG) formulation | Participants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously using Concerta for at least 60 days. Participants who will switch from Concerta to AG formulation will be observed. |
| |
| Concerta to equivalent generic (EG) formulation | Participants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously using Concerta for at least 60 days. Participants who will switch from Concerta to EG formulation will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concerta | Drug | This is an observational study. Participants who have been on Concerta for at least 60 days will be observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Switching Back to Concerta | 60 Days after index date (the date when participant switches from Concerta to an AG or EG) | |
| Number of Participants Changing the use of Immediate Release (IR) Methylphenidate | 60 Days after index date (the date when participant switches from Concerta to an AG or EG) | |
| Number of Participants Starting a new Different Attention Deficit Hyperactivity Disorder (ADHD) Medication | 60 Days before index date (the date when participant switches from Concerta to an AG or EG) | |
| Number of Participants Discontinuing the use of Both Concerta and the Study Drug to Which the Participant is Switched | 60 Days after index date (the date when participant switches from Concerta to an AG or EG) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Changing the use of Immediate Release (IR) Methylphenidate | 60 Days before and after index (the date when participant switches from Concerta to an AG or EG) | |
| Number of Participants Starting a new Different Attention Deficit Hyperactivity Disorder (ADHD) Medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in the study will have a confirmed diagnosis of ADHD and continuously used Concerta brand of methylphenidate for at least 60 days and receive a dispensing of the AG or EG formulation within 15 days of the end of the days of Concerta supplied.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29489906 | Derived | Fife D, Cepeda MS, Baseman A, Richards H, Hu P, Starr HL, Sena AG. Medication changes after switching from CONCERTA(R) brand methylphenidate HCl to a generic long-acting formulation: A retrospective database study. PLoS One. 2018 Feb 28;13(2):e0193453. doi: 10.1371/journal.pone.0193453. eCollection 2018. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Concerta AG formulation | Drug | This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed. |
|
|
| Concerta EG formulation | Drug | This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed. |
|
|
| 60 Days after index date (the date when participant switches from Concerta to an AG or EG) |
| Number of Participants Changing an Established Methylphenidate | 60 Days after index date (the date when participant switches from Concerta to an AG or EG) |
| Number of Participants Having Outpatient Visits for ADHD | 60 days after the index date (the date when participant switches from Concerta to an AG or EG) |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |