Concerta
DrugThis is an observational study. Participants who have been on Concerta for at least 60 days will be observed.
Other names: Methylphenidate
NCT Number: NCT02730572
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.
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Notify Me6 year–65 year
All sexes
Observational
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.
Other names: Methylphenidate
This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.
Other names: Methylphenidate
This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.
Other names: Methylphenidate
Time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days before index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days before and after index (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 Days after index date (the date when participant switches from Concerta to an AG or EG)
Time frame: 60 days after the index date (the date when participant switches from Concerta to an AG or EG)
Janssen Research & Development, LLC
Industry
Concerta-to-Generic Switch Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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